ID

36201

Beschreibung

Study ID: 101963 Clinical Study ID: SCA101963 Study Title: A randomised, blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and risperidone in healthy, non-smoking, male volunteers. 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: lamotrigine Trade Name: Lamictal XR,Lamictal,LAMICTIN Study Indication: Schizophrenia

Stichworte

Versionen (1)
  1. 22.04.19 22.04.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

22. April 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963

Englisch

Period 2 Day 64

1 Formulare  
  1. StudyEvent: ODM
    1. Period 2 Day 64
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beschreibung

Vital Signs Date

Datentyp

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time
Beschreibung

Vital Signs, Relative time, Planned

Datentyp

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Actual Time
Beschreibung

Vital Signs Time

Datentyp

text

Alias
UMLS CUI [1]
C2826762
Blood Pressure - Systolic
Beschreibung

Systolic Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure - Diastolic
Beschreibung

Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject Position
Beschreibung

Standing, Semi-Supine

Datentyp

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1262869
Heart Rate
Beschreibung

Heart Rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Electronically transferred laboratory data - Clinical Chemistry, Haematology
Beschreibung

Electronically transferred laboratory data - Clinical Chemistry, Haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Planned Relative Time
Beschreibung

Chemistry, Clinical, Hematologic tests, Relative time, Planned

Datentyp

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0439564
UMLS CUI [1,4]
C1301732
Date Sample Taken
Beschreibung

Chemistry, Clinical, Hematologic tests, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Beschreibung

Chemistry, Clinical, Hematologic tests, Sampling, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Electronically transferred laboratory data - Urinalysis
Beschreibung

Electronically transferred laboratory data - Urinalysis

Alias
UMLS CUI-1
C0042014
Planned Relative Time
Beschreibung

Urinalysis, Relative time, Planned

Datentyp

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Date Sample Taken
Beschreibung

Urinalysis, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Beschreibung

Urinalysis, Sampling, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0040223
12-Lead ECG
Beschreibung

12-Lead ECG

Alias
UMLS CUI-1
C0430456
No.
Beschreibung

12 lead ECG, Numbers

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0237753
Start Date of ECG
Beschreibung

12 lead ECG, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned Relative Time
Beschreibung

12 lead ECG, Relative time, Planned

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Start Time of ECG
Beschreibung

12 lead ECG, Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Ventricular Rate
Beschreibung

12 lead ECG, Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
bpm
PR Interval
Beschreibung

12 lead ECG, PR Interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Beschreibung

12 lead ECG, QRS complex duration

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Beschreibung

12 lead ECG, QT Interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Beschreibung

12 lead ECG, QT corrected Interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Result of the ECG
Beschreibung

12 lead ECG, Result

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
II Lead ECG
Beschreibung

II Lead ECG

Alias
UMLS CUI-1
C1623258
Start date of ECG
Beschreibung

Electrocardiography, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0808070
Start time of ECG
Beschreibung

Electrocardiography, Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1301880
End date of ECG
Beschreibung

Electrocardiography, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0806020
End time of ECG
Beschreibung

Electrocardiography, End Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1522314
Result of the ECG
Beschreibung

Electrocardiography, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1274040
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C0304229
Planned Timepoint
Beschreibung

Experimental drug, Timepoint, Planned

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2348792
UMLS CUI [1,3]
C1301732
Investigational Product
Beschreibung

Experimental drug

Datentyp

text

Alias
UMLS CUI [1]
C0304229
Date of Dose
Beschreibung

Experimental drug, Dosage, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Dose
Beschreibung

Experimental drug, Dosage, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Pharmacokinetics - Blood
Beschreibung

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beschreibung

Time Relative to Risperidone and Quetiapins

Datentyp

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0439564
UMLS CUI [1,4]
C1301732
Date Sample Taken
Beschreibung

Pharmacokinetic aspects, Blood, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Beschreibung

Pharmacokinetic aspects, Blood, Sampling, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Sample Number
Beschreibung

Pharmacokinetic aspects, Blood, Sampling, Numbers

Datentyp

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0237753
Pharmacokinetics - Blood
Beschreibung

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beschreibung

Time Relative to Lamatrigine

Datentyp

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0439564
UMLS CUI [1,4]
C1301732
Date Sample Taken
Beschreibung

Pharmacokinetic aspects, Blood, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Beschreibung

Pharmacokinetic aspects, Blood, Sampling, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Sample Number
Beschreibung

Pharmacokinetic aspects, Blood, Sampling, Numbers

Datentyp

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0237753
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Ähnliche Modelle

Period 2 Day 64

1 Formulare
  1. StudyEvent: ODM
    1. Period 2 Day 64
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital Signs Date
Item
Date
date
C2826644 (UMLS CUI [1])
Item
Planned Relative Time
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Vital Signs, Relative time, Planned
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
Pre-dose (2)
CL Item
+0.5 hr (3)
CL Item
+1 hr (4)
CL Item
+1.5 hr (5)
CL Item
+2 hr (6)
CL Item
+3 hr (7)
CL Item
+4 hr (8)
CL Item
+6 hr (9)
CL Item
+6 hr (10)
CL Item
+8 hr (11)
CL Item
+12 hr (12)
CL Item
+12 hr (13)
CL Item
+24 hr (14)
CL Item
+24 hr (15)
Vital Signs Time
Item
Actual Time
text
C2826762 (UMLS CUI [1])
Systolic Pressure
Item
Blood Pressure - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood Pressure - Diastolic
integer
C0428883 (UMLS CUI [1])
Vital Signs, Body Position
Item
Subject Position
text
C0518766 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Electronically transferred laboratory data - Clinical Chemistry, Haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Item
Planned Relative Time
text
C0008000 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Chemistry, Clinical, Hematologic tests, Relative time, Planned
Code List
Planned Relative Time
CL Item
+24 hrs (1)
Chemistry, Clinical, Hematologic tests, Sampling, Date in time
Item
Date Sample Taken
date
C0008000 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Chemistry, Clinical, Hematologic tests, Sampling, Time
Item
Actual Time
time
C0008000 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Electronically transferred laboratory data - Urinalysis
C0042014 (UMLS CUI-1)
Item
Planned Relative Time
text
C0042014 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Urinalysis, Relative time, Planned
Code List
Planned Relative Time
CL Item
+24 hrs (1)
Urinalysis, Sampling, Date in time
Item
Date Sample Taken
date
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Urinalysis, Sampling, Time
Item
Actual Time
time
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Item
No.
text
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
12 lead ECG, Numbers
Code List
No.
CL Item
ECG1 (1)
CL Item
ECG2 (2)
CL Item
ECG3 (3)
CL Item
ECG4 (4)
CL Item
ECG5 (5)
CL Item
ECG6 (6)
12 lead ECG, Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
12 lead ECG, Relative time, Planned
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
+ 2 hrs (2)
CL Item
+ 4 hrs (3)
CL Item
+ 8 hrs (4)
CL Item
+ 12 hrs (5)
CL Item
+ 24 hrs (6)
12 lead ECG, Start Time
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
12 lead ECG, Heart rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
12 lead ECG, PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 lead ECG, QT Interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
12 lead ECG, QT corrected Interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
12 lead ECG, Result
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal- clinically significant (3)
CL Item
No result (not available) (4)
Item Group
II Lead ECG
C1623258 (UMLS CUI-1)
Electrocardiography, Start Date
Item
Start date of ECG
date
C1623258 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Electrocardiography, Start Time
Item
Start time of ECG
time
C1623258 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Electrocardiography, End Date
Item
End date of ECG
date
C1623258 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Electrocardiography, End Time
Item
End time of ECG
time
C1623258 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Result of the ECG
text
C1623258 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Holter Electrocardiography, Result
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
Planned Timepoint
text
C0304229 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Experimental drug, Timepoint, Planned
Code List
Planned Timepoint
CL Item
Day 64 - AM (1)
CL Item
Day 64 - PM (2)
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Experimental drug, Timepoint, Planned
Code List
Investigational Product
CL Item
Lamotrigine plus Quetiapine 25mg or Risperidone 2mg (1)
CL Item
Lamotrigine (2)
Experimental drug, Dosage, Date in time
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Experimental drug, Dosage, Time
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Pharmacokinetics - Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Relative time, Planned
Code List
Planned Relative Time
CL Item
Day 1 Pre-dose (1)
CL Item
+0.5 hr (2)
CL Item
+1 hrs (3)
CL Item
+1.5 hrs (4)
CL Item
+2 hrs (5)
CL Item
+2.5 hrs (6)
CL Item
+3 hrs (7)
CL Item
+4 hrs (8)
CL Item
+6 hrs (9)
CL Item
+8 hrs (10)
CL Item
+10 hrs (11)
CL Item
+12 hrs (12)
CL Item
+16 hrs (13)
CL Item
+24 hrs (14)
CL Item
+36 hrs (15)
CL Item
+48 hrs (16)
CL Item
+72 hrs (Risperidone only) (17)
CL Item
+96 hrs (Risperidone only) (18)
Pharmacokinetic aspects, Blood, Sampling, Date in time
Item
Date Sample Taken
date
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Sampling, Time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Sample Number
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Sampling, Numbers
Code List
Sample Number
CL Item
201 (1)
CL Item
202 (2)
CL Item
203  (3)
CL Item
204  (4)
CL Item
205  (5)
CL Item
206  (6)
CL Item
207  (7)
CL Item
208  (8)
CL Item
209  (9)
CL Item
210  (10)
CL Item
211  (11)
CL Item
212  (12)
CL Item
213  (13)
CL Item
214  (14)
CL Item
215 (15)
CL Item
216 (16)
CL Item
217 (17)
CL Item
218 (18)
Item Group
Pharmacokinetics - Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Relative time, Planned
Code List
Planned Relative Time
CL Item
Pre-dose (1)
Pharmacokinetic aspects, Blood, Sampling, Date in time
Item
Date Sample Taken
date
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Sampling, Time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Sample Number
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Sampling, Numbers
Code List
Sample Number
CL Item
221 (1)
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