Informationen:
Fehler:
ID
26602
Beschreibung
Study ID: 101468/199 Clinical Study ID: 101468/199 Study Title: An open label study conducted in healthy volunteers to characterize the pharmacokinetics of a new unmarketed formulation of ropinirole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome Documentation part: Screening
Stichworte
Versionen (1)
- 21.10.17 21.10.17 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
21. Oktober 2017
DOI
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Creative Commons BY-NC 3.0
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Pharmacokinetics of a new unmarketed formulation of ropinirole Screening 101468/199
Ähnliche Modelle
Screening
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Female (F)
CL Item
Male (M)
CL Item
American Indian or Alaskan Native (2)
(Comment:en)
CL Item
Asian - Central/South Asian Heritage (3)
(Comment:en)
CL Item
Asian - East Asian Heritage (4)
(Comment:en)
CL Item
Asian - Japanese Heritage (5)
(Comment:en)
CL Item
Asian - South East Asian Heritage (6)
(Comment:en)
CL Item
Native Hawaiian or Other Pacific Islander (7)
(Comment:en)
CL Item
African American/African Heritage (1)
CL Item
White - Arabic/North African Heritage (8)
CL Item
White - White/Caucasian/European Heritage (9)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Planned Relative Time
Item
Planned Relative Time
text
C0439564 (UMLS CUI [1])
Actual time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure
integer
C0428883 (UMLS CUI [1])
CL Item
Supine (1)
CL Item
Standing (2)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
CL Item
Current (1)
CL Item
Past (2)
physical examination
Item
Has a physical examination been performed on the subject?
boolean
C0031809 (UMLS CUI [1])
physical examination finding
Item
Was the physical examination normal?
boolean
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
Physical examination abnormal
Item
If Abnormal record below:
text
C0031809 (UMLS CUI [1,1])
C0459424 (UMLS CUI [1,2])
C0459424 (UMLS CUI [1,2])
Item Group
Laboratory Result Data Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0474523 (UMLS CUI-2)
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
haemoglobin
Item
haemoglobin
float
C0518015 (UMLS CUI [1])
haematocrit
Item
haematocrit
float
C0018935 (UMLS CUI [1])
red blood cell
Item
red blood cell count
float
C0014772 (UMLS CUI [1])
WBC
Item
WBC (White Blood Cell count)
float
C0023508 (UMLS CUI [1])
platelet count
Item
platelet count
float
C0005821 (UMLS CUI [1])
Differential WBC count
Item
Differential WBC count
float
C0162401 (UMLS CUI [1])
Mean cell haemoglobin (MCH)
Item
Mean cell haemoglobin (MCH)
float
C0369183 (UMLS CUI [1])
Mean cell haemoglobin concentration (MCHC)
Item
Mean cell haemoglobin concentration (MCHC)
float
C0474535 (UMLS CUI [1])
Item Group
Laboratory Result Data Clinical Chemistry
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0587081 (UMLS CUI-3)
C0022885 (UMLS CUI-2)
C0587081 (UMLS CUI-3)
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Urea
Item
Urea
float
C0523961 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Albumin/globulin ratio
Item
Albumin/globulin ratio
float
C0201837 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
Alkaline phosphatase (AP)
Item
Alkaline phosphatase (AP)
float
C0201850 (UMLS CUI [1])
Gamma glutamyl transferase (GGT)
Item
Gamma glutamyl transferase (GGT)
float
C0202035 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Phosphate
Item
Phosphate
float
C0523826 (UMLS CUI [1])
Cholesterol
Item
Cholesterol
float
C1445957 (UMLS CUI [1])
Triglycerides
Item
Triglycerides
float
C0202236 (UMLS CUI [1])
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1])
Creatine phosphokinase
Item
Creatine phosphokinase
float
C0201973 (UMLS CUI [1])
Iron
Item
Iron
float
C0337439 (UMLS CUI [1])
Total Iron Binding Capacity
Item
Total Iron Binding Capacity
float
C1283048 (UMLS CUI [1])
Ferritin
Item
Ferritin
float
C0015879 (UMLS CUI [1])
Transferrin
Item
Transferrin
float
C0202105 (UMLS CUI [1])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1])
FSH/LH
Item
FSH/LH
float
C2122182 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,2])
Item Group
Urinalysis, Dipstick Test
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
Urine sample date
Item
Urine sample date
date
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Urine sample time
Item
Urine sample time
time
C0200354 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item
Result of dipstick
integer
C0430370 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
CL Item
Negative (1)
CL Item
Positive. If positive, record results of individual tests below. (2)
CL Item
No Result (3)
Item
Urine Dipstick: Proteins
integer
C0428541 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0430370 (UMLS CUI [1,2])
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
Item
Urine Dipstick: Glucose
integer
C0004076 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0430370 (UMLS CUI [1,2])
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
Item
Urine Dipstick: pH
integer
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0430370 (UMLS CUI [1,2])
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
Item
Urine Dipstick: Bilirubin
integer
C0430374 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0430370 (UMLS CUI [1,2])
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
Item
Urine Dipstick: Blood
integer
C0430372 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0430370 (UMLS CUI [1,2])
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
Item
Urine Dipstick: Specific gravity
integer
C0202517 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0430370 (UMLS CUI [1,2])
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
sedimentary microscopy
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,2])
casts
Item
Urinalysis (Microscopy) Test: Casts
text
C4048266 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
C0430397 (UMLS CUI [1,2])
Cells
Item
Urinalysis (Microscopy) Test: Cells
text
C0919738 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
C0430397 (UMLS CUI [1,2])
Date blood sample taken
Item
Date blood sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Positive (P)
CL Item
Negative (N)
Item
Hepatitis B surface antigen
text
C0019168 (UMLS CUI [1,1])
C1278302 (UMLS CUI [1,2])
C1278302 (UMLS CUI [1,2])
CL Item
Positive (P)
CL Item
Negative (N)
Item
Hepatitis C antibody
text
C0201487 (UMLS CUI [1,1])
C0871311 (UMLS CUI [1,2])
C0871311 (UMLS CUI [1,2])
CL Item
Positive (P)
CL Item
Negative (N)
Item Group
Drug Screen
C0373483 (UMLS CUI-1)
C0202274 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0202274 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
Date urine sample taken
Item
Date urine sample taken
date
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken
time
C0200354 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
CL Item
Positive (P)
CL Item
Negative (N)
CL Item
Positive (P)
CL Item
Negative (N)
CL Item
Positive (P)
CL Item
Negative (N)
CL Item
Positive (P)
CL Item
Negative (N)
CL Item
Positive (P)
CL Item
Negative (N)
CL Item
Positive (P)
CL Item
Negative (N)
Item
Tricyclic antidepressants
text
C0202274 (UMLS CUI [1,1])
C0003290 (UMLS CUI [1,2])
C0003290 (UMLS CUI [1,2])
CL Item
Positive (P)
CL Item
Negative (N)
CL Item
Positive (P)
CL Item
Negative (N)
Item
Morphine Derivatives
text
C0202274 (UMLS CUI [1,1])
C0279996 (UMLS CUI [1,2])
C0279996 (UMLS CUI [1,2])
CL Item
Positive (P)
CL Item
Negative (N)
alcohol breath test date
Item
Date sample taken for alcohol breath test
date
C0202306 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Alcohol breath test Results
text
C0202306 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Positive (P)
CL Item
Negative (N)
Date sample taken
Item
Date sample taken for Pregnancy test
boolean
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy test Result
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Positive (P)
CL Item
Negative (N)
CL Item
Not applicable (Not of childbearing potential) (NA)
Item Group
12-lead ECG
C0430456 (UMLS CUI-1)
C1623258 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
C1623258 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Planned Relative Time ECG
Item
Planned Relative Time ECG
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Ventricular Rate
Item
Ventricular Rate
integer
C2189285 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
QTc Interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal- clinically significant (3)
CL Item
No result (not available) (4)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Item
Rhythm Abnormalities
integer
C0199556 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (1)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (2)
CL Item
Sinus bradycardia (heart rate < 30 beats/min) (3)
CL Item
Sinus pause (4)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (5)
CL Item
Ectopic supraventricular beats (6)
CL Item
Ectopic supraventricular rhythm (7)
CL Item
Wandering atrial pacemaker (8)
CL Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (9)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (10)
CL Item
Atrial flutter (11)
CL Item
Atrial fibrillation (12)
CL Item
unctional rhythm (heart rate ≤100 beats/min) (13)
CL Item
Junctional rhythm (14)
CL Item
Junctional tachycardia (heart rate > 100 beats/min) (15)
CL Item
Ectopic ventricular beats (16)
CL Item
Ventricular couplets (17)
CL Item
Bigeminy (18)
CL Item
Trigeminy (19)
CL Item
Electrical alternans (20)
CL Item
R on T phenomenon (21)
CL Item
Ventricular fibrillation (22)
CL Item
Idioventricular rhythm (heart rate < 100 beats/min) (23)
CL Item
Sustained ventricular tachycardia (24)
CL Item
Non-sustained ventricular tachycardia (25)
CL Item
Ventricular tachycardia (26)
CL Item
Monomorphic ventricular tachycardia (27)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (28)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (29)
CL Item
Artificial pacemaker (30)
CL Item
Other abnormal rhythm (31)
Rhythm Abnormalities
Item
Rhythm Abnormalities, if Other please specify
text
C0199556 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
Item
P-Wave and QRS Morphology Abnormalities
integer
C2216025 (UMLS CUI [1])
C0429098 (UMLS CUI [2])
C1704258 (UMLS CUI [3,1])
C0430456 (UMLS CUI [3,2])
C0429098 (UMLS CUI [2])
C1704258 (UMLS CUI [3,1])
C0430456 (UMLS CUI [3,2])
CL Item
Left atrial abnormality (P mitrale) (1)
CL Item
Right atrial abnormality (P pulmonale) (2)
CL Item
Right ventricular hypertrophy (3)
CL Item
Intraatrial conduction delay (4)
CL Item
Increased voltage consistent with left ventricular hypertrophy (5)
CL Item
Other morphology (6)
P-Wave and QRS Morphology Abnormalities
Item
P-Wave and QRS Morphology Abnormalities, if Other please specify
text
C2216025 (UMLS CUI [1])
C0429098 (UMLS CUI [2])
C1704258 (UMLS CUI [3,1])
C0430456 (UMLS CUI [3,2])
C0429098 (UMLS CUI [2])
C1704258 (UMLS CUI [3,1])
C0430456 (UMLS CUI [3,2])
Item
Conduction Abnormalities
integer
C0232219 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
CL Item
First degree AV block (PR interval > 200 msec) (1)
CL Item
Second degree AV block (Mobitz type 1) (2)
CL Item
Second degree AV block (Mobitz type 2) (3)
CL Item
2:1 AV block (4)
CL Item
Third degree AV block (5)
CL Item
Left axis deviation (QRS axis more negative than -30°) (6)
CL Item
Right axis deviation (QRS axis more positive than +110°) (7)
CL Item
Incomplete right bundle branch block (8)
CL Item
Incomplete left bundle branch block (9)
CL Item
Right bundle branch block (10)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (11)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (12)
CL Item
Left bundle branch block (13)
CL Item
Bifascicular block (14)
CL Item
Non-specific intraventricular conduction delay (QRS ≥ 120 msec) (15)
CL Item
QT/QTc prolongation ≥ 500 msec (17)
CL Item
AV dissociation (18)
CL Item
Other conduction (19)
Conduction Abnormalities
Item
Conduction Abnormalities, if Other please specify
text
C0232219 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
Item
Myocardial Infarction
integer
C0027051 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
CL Item
Myocardial infarction, old (1)
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Myocardial infarction, anterior (2)
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Myocardial infarction, lateral (3)
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Myocardial infarction, posterior (4)
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Myocardial infarction, inferior (5)
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Myocardial infarction, septal (6)
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Myocardial infarction, Non-Q wave (7)
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Other myocardial infarction (8)
Myocardial Infarction
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Myocardial Infarction, if Other please specify
text
C0027051 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
Item
Depolarisation/Repolarisation (QRS-T) Abnormalities
integer
C0948857 (UMLS CUI [1])
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Non-specific ST-T changes (1)
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J point elevation (2)
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ST elevation (3)
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ST elevation-pericarditis (4)
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ST depression (5)
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U waves abnormal (6)
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T wave inversion (7)
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T wave peaked (8)
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T waves flat (9)
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T waves biphasic (10)
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Notched T-waves (11)
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Low QRS voltage (12)
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T-wave flattening/inversion (13)
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Other depolarisation/repolarisation (14)
Repolarisation Abnormalities
Item
Depolarisation/Repolarisation (QRS-T) Abnormalities, if Other please specify
text
C0948857 (UMLS CUI [1])
Other ECG Abnormalities
Item
Other ECG Abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Other ECG Abnormalities
Item
Other ECG Abnormalities, please specify
text
C1704258 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
C0244821 (UMLS CUI-2)
C0031327 (UMLS CUI-3)
C0244821 (UMLS CUI-2)
C0031327 (UMLS CUI-3)
entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
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Healthy, male and female subjects between 18 and 55 years of age inclusive. (1)
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Body mass index of 19 to 29 kg/m2, with a body weight of at least 50kg. (2)
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No abnormality on clinical examination. A subject with a clinical abnormality may be included only if the Principal Investigator, in agreement with the Sponsor, considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedures. (3)
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No abnormality revealed by the clinical laboratory parameters examination at the pre study medical examination. Subjects with laboratory values outside the reference range for this age group will only be included if the Principal Investigator considers that such findings will not introduce risk factors. (4)
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A normal 12-lead ECG at the pre-study screening. (5)
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Normal systolic (100-400mmHg) and diastolic (<90mmHg) blood pressure (Supine) at pre study screening and pre-dose Day 1. (6)
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Written informed consent prior to admission to the study. (7)
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Subjects who smoke > 10 cigarettes per day. (1)
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Any clinically relevant abnormality identified on the screening 12-lead ECG: QTcB interval >430 msec (male or >450 msec (female) (2)
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History or presence of clinically significant cardiovascular, neurological, psychiatric, haematological or renal abnormalities. (3)
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History of postural hypotension or faints. (4)
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Supine Systolic BP <100mmHg and diastolic BP < 60mmHg at screening. (5)
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Orthostatic decrease (supine to erect) in BP for systolic > 20mmHg and diastolic > 10mmHg at screening. (6)
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History or presence of gastrointestinal, hepatic or renal disease or any other condition known to (7)
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The subject has received prescribed medication within 14 days or over-the-counter (OTC) medicine within 7 days before the first dosing day (apart from medications that are described below in 6 and 7), which in the opinion of the Principal Investigator may interfere with the study procedures or compromise a subjects’ safety. Subjects who have taken OTC medication may still be entered into the study, if, in the opinion of the Principal/Co-investigator in agreement with the Sponsor, the medication received will not interfere with the study procedures or compromise subjects’ safety. (8)
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The subject has received prescribed medication within 14 days or over-the-counter (OTC) medicine within 7 days before the first dosing day (apart from medications that are described below in 6 and 7), which in the opinion of the Principal Investigator may interfere with the study procedures or compromise a subjects’ safety. Subjects who have taken OTC medication may still be entered into the study, if, in the opinion of the Principal/Co-investigator in agreement with the Sponsor, the medication received will not interfere with the study procedures or compromise subjects’ safety. (8)
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Women on cyclic HRT treatments during which the proportions of oestrogen and progesterone are not kept constant throughout their 28-day cycle. (9)
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Withdrawal, introduction, or change in dose of any drug known to substantially inhibit CY1A2 (e.g.ciprofoxcin, fluvoxamine, cimetidine, ethinylostradiol) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to first day of dosing. Subjects who are on stable doses (no change within 7 days of 1st dose) or any CYP1A2 inhibitors or inducers are permitted to participate, if, in the opinion of the Principal investigator and in agreement with the Sponsor, the medication received will not interfere with the study procedures or compromise subjects’ safety. (10)
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Pregnancy and/or breast feeding. (11)
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Females of child-bearing potential who are not practising a clinically accepted method of contraception such as surgical sterilisation, I.U.D.,diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant). Males subjects with female partners must also pratice a clinically accepted method of contraception. (12)
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Female subjects with positive urine/serum pregnancy test result at screening or prior to first dose. (13)
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Recent history (within the last 6 months), or suspicion, of drug dependence or a positive screening or pre-dose drugs of abuse screen. (14)
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Abuse of alcohol (defined as an average weekly intake of greater than 21 units or and average daily intake greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women. One unit is equivalent to half a pint of beer, one measure of spirits or one glass of wine) or a positive screening or pre-dose alcohol test. (15)
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Positive pre-study screening result for hepatitis B surface antigen, hepatitis C antibody or HIV - 1/2 antibodies. (16.)
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Participation in another clinical trial, blood donation less than 90 days before the present study. (17)
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Definite or suspected personal history or family history or adverse reactions or hypersensitivity to the study drug or to drugs with a similar chemical structure. (18)