ID

29562

Beschreibung

Study ID: 102587 Clinical Study ID: EGF102587 Study Title: A Single-Dose, Open-Label, Randomized, Three-Way Cross-Over Study in Healthy Subjects to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib (GW572016) Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tykerb,Tycerb,Tyverb; Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Breast Documentation part: Period 3

Stichworte

Versionen (2)
  1. 05.04.18 05.04.18 -
  2. 16.04.18 16.04.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. April 2018

DOI

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Creative Commons BY-NC 3.0
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Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib in Healthy Subjects GSK102587

Englisch

Period 3

1 Formulare  
  1. StudyEvent: ODM
    1. Period 3
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Vital Signs Date
Beschreibung

Vital Signs Date

Datentyp

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time Vital Signs
Beschreibung

Planned Relative Time Vital Signs

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2348792
Actual Time Vital Signs
Beschreibung

Actual Time Vital Signs

Datentyp

time

Alias
UMLS CUI [1]
C2826762
Blood Pressure systolic
Beschreibung

Blood Pressure systolic

Datentyp

integer

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

Blood Pressure diastolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Beschreibung

Heart Rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Drug and Alcohol Screen
Beschreibung

Drug and Alcohol Screen

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0038586
UMLS CUI-3
C0948726
Date sample taken Drug and Alcohol Screen
Beschreibung

Date sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1302413
Time sample taken Drug and Alcohol Screen
Beschreibung

Time sample taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Cocaine
Beschreibung

Cocaine

Datentyp

integer

Alias
UMLS CUI [1]
C0009170
Amphetamines
Beschreibung

Amphetamines

Datentyp

integer

Alias
UMLS CUI [1]
C0002667
Benzodiazepines
Beschreibung

Benzodiazepines

Datentyp

integer

Alias
UMLS CUI [1]
C0005064
Cannabis metabolites
Beschreibung

Cannabis metabolites

Datentyp

integer

Alias
UMLS CUI [1,1]
C0936079
UMLS CUI [1,2]
C0870883
Opiates
Beschreibung

Opiates

Datentyp

integer

Alias
UMLS CUI [1]
C0376196
Barbiturates
Beschreibung

Barbiturates

Datentyp

integer

Alias
UMLS CUI [1]
C0004745
PCP
Beschreibung

PCP

Datentyp

integer

Alias
UMLS CUI [1]
C0031381
Alcohol
Beschreibung

Alcohol

Datentyp

integer

Alias
UMLS CUI [1]
C0202304
UMLS CUI [2]
C0001948
Local Laboratory - Haematology
Beschreibung

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0474523
UMLS CUI-2
C0022885
Lab ID
Beschreibung

Lab ID

Datentyp

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0600091
Date Sample taken Haematology
Beschreibung

Date Sample taken Haematology

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1302413
Time sample taken Haematology
Beschreibung

Time sample taken Haematology

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0040223
Planned Relative Time Haematology
Beschreibung

Planned Relative Time Haematology

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0439564
Haemoglobin (Hb)
Beschreibung

Haemoglobin (Hb)

Datentyp

text

Alias
UMLS CUI [1]
C0518015
Haematocrit (HCT)
Beschreibung

Haematocrit (HCT)

Datentyp

text

Alias
UMLS CUI [1]
C0018935
Platelet count (absolute)
Beschreibung

Platelet count (absolute)

Datentyp

text

Alias
UMLS CUI [1]
C0032181
White blood cell count (WBC) (Absolute)
Beschreibung

White blood cell count (WBC) (Absolute)

Datentyp

text

Alias
UMLS CUI [1]
C0023508
Neutrophil count (absolute)
Beschreibung

Neutrophil count (absolute)

Datentyp

text

Alias
UMLS CUI [1]
C0948762
Lymphocyte count (absolute)
Beschreibung

Lymphocyte count (absolute)

Datentyp

text

Alias
UMLS CUI [1]
C3544087
Monocyte count (absolute)
Beschreibung

Monocyte count (absolute)

Datentyp

text

Alias
UMLS CUI [1]
C0200637
Eosinophil count (absolute)
Beschreibung

Eosinophil count (absolute)

Datentyp

text

Alias
UMLS CUI [1]
C0200638
Basophil count (absolute)
Beschreibung

Basophil count (absolute)

Datentyp

text

Alias
UMLS CUI [1]
C0200641
Local Laboratory - Clinical Chemistry
Beschreibung

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0022885
Lab ID
Beschreibung

Lab ID

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0600091
Date sample taken clinical chemistry
Beschreibung

Date sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1302413
Time Sample Taken Clinical Chemistry
Beschreibung

Time Sample Taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0040223
Planned Relative Time Clinical Chemistry
Beschreibung

Planned Relative Time

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0439564
Sodium
Beschreibung

Sodium

Datentyp

float

Alias
UMLS CUI [1]
C0337443
Potassium
Beschreibung

Potassium

Datentyp

float

Alias
UMLS CUI [1]
C0202194
Calcium
Beschreibung

Calcium

Datentyp

float

Alias
UMLS CUI [1]
C0201925
Glucose (fasting)
Beschreibung

Glucose (fasting)

Datentyp

float

Alias
UMLS CUI [1]
C0583513
Total Protein
Beschreibung

Total Protein

Datentyp

float

Alias
UMLS CUI [1]
C0555903
Albumin
Beschreibung

Albumin

Datentyp

float

Alias
UMLS CUI [1]
C0201838
Total bilirubin
Beschreibung

Total bilirubin

Datentyp

float

Alias
UMLS CUI [1]
C0201913
Alkaline phosphatase
Beschreibung

Alkaline phosphatase

Datentyp

float

Alias
UMLS CUI [1]
C0201850
AST (SGOT)
Beschreibung

AST (SGOT)

Datentyp

float

Alias
UMLS CUI [1]
C0201899
ALT (SGPT)
Beschreibung

ALT (SGPT)

Datentyp

float

Alias
UMLS CUI [1]
C0201836
Serum Creatinine
Beschreibung

Serum Creatinine

Datentyp

float

Alias
UMLS CUI [1]
C0201976
Blood Urea Nitrogen
Beschreibung

BUN

Datentyp

float

Alias
UMLS CUI [1]
C0005845
LDH
Beschreibung

LDH

Datentyp

float

Alias
UMLS CUI [1]
C0202113
Creatine Phosphokinase (CPK)
Beschreibung

Creatine Phosphokinase (CPK)

Datentyp

float

Alias
UMLS CUI [1]
C0201973
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C0304229
Did the subject fast for 10 hours prior to dosing?
Beschreibung

fasting status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015663
UMLS CUI [1,2]
C0304229
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beschreibung

correct treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013227
If No, record reason(s)
Beschreibung

reason correct treatment not recieved

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0392360
Investigational Product
Beschreibung

Investigational Product

Datentyp

integer

Alias
UMLS CUI [1]
C0304229
Date of Dose
Beschreibung

Date of Dose

Datentyp

date

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

Time of Dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
Total Daily Dose
Beschreibung

Total Daily Dose

Datentyp

float

Maßeinheiten
  • mg/Day
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0304229
mg/Day
Pharmacokinetics - Blood
Beschreibung

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0304229
UMLS CUI-3
C0005834
Planned Relative Time, check one
Beschreibung

Time Relative to Dosing

Datentyp

integer

Alias
UMLS CUI [1]
C0439564
UMLS CUI [2]
C0005834
Date Blood Sample Taken
Beschreibung

Date Blood Sample Taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1302413
Time Blood Sample Taken
Beschreibung

Time Blood Sample Taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
2 mL Aliquot, check if taken
Beschreibung

Aliquot sample taken

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C1510844
Sample Number
Beschreibung

Sample Number

Datentyp

integer

Alias
UMLS CUI [1]
C1299222
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Ähnliche Modelle

Period 3

1 Formulare
  1. StudyEvent: ODM
    1. Period 3
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Vital Signs Date
Item
Vital Signs Date
date
C2826644 (UMLS CUI [1])
Item
Planned Relative Time Vital Signs
integer
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Planned Relative Time Vital Signs
Code List
Planned Relative Time Vital Signs
CL Item
15 min (1)
CL Item
Check-in (2)
CL Item
4 hrs post-dose (3)
CL Item
Check-out (4)
Actual Time Vital Signs
Item
Actual Time Vital Signs
time
C2826762 (UMLS CUI [1])
Blood Pressure systolic
Item
Blood Pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure diastolic
Item
Blood Pressure diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Drug and Alcohol Screen
C0373483 (UMLS CUI-1)
C0038586 (UMLS CUI-2)
C0948726 (UMLS CUI-3)
Date sample taken
Item
Date sample taken Drug and Alcohol Screen
date
C0005834 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken Drug and Alcohol Screen
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Cocaine
integer
C0009170 (UMLS CUI [1])
Cocaine
Code List
Cocaine
CL Item
positive (1)
CL Item
negative (2)
Item
Amphetamines
integer
C0002667 (UMLS CUI [1])
Cocaine
Code List
Amphetamines
CL Item
positive (1)
CL Item
negative (2)
Item
Benzodiazepines
integer
C0005064 (UMLS CUI [1])
Cocaine
Code List
Benzodiazepines
CL Item
positive (1)
CL Item
negative (2)
Item
Cannabis metabolites
integer
C0936079 (UMLS CUI [1,1])
C0870883 (UMLS CUI [1,2])
Cocaine
Code List
Cannabis metabolites
CL Item
positive (1)
CL Item
negative (2)
Item
Opiates
integer
C0376196 (UMLS CUI [1])
Cocaine
Code List
Opiates
CL Item
positive (1)
CL Item
negative (2)
Item
Barbiturates
integer
C0004745 (UMLS CUI [1])
Cocaine
Code List
Barbiturates
CL Item
positive (1)
CL Item
negative (2)
Item
PCP
integer
C0031381 (UMLS CUI [1])
Cocaine
Code List
PCP
CL Item
positive (1)
CL Item
negative (2)
Item
Alcohol
integer
C0202304 (UMLS CUI [1])
C0001948 (UMLS CUI [2])
Cocaine
Code List
Alcohol
CL Item
positive (1)
CL Item
negative (2)
Item Group
Local Laboratory - Haematology
C0474523 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Lab ID
Item
Lab ID
text
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date Sample taken Haematology
Item
Date Sample taken Haematology
date
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Time sample taken Haematology
Item
Time sample taken Haematology
time
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Planned Relative Time Haematology
integer
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Planned Relative Time Haematology
Code List
Planned Relative Time Haematology
CL Item
Check-in (Result 1) (1)
CL Item
24 hours post-dose (Result 2) (2)
Haemoglobin (Hb)
Item
Haemoglobin (Hb)
text
C0518015 (UMLS CUI [1])
Haematocrit (HCT)
Item
Haematocrit (HCT)
text
C0018935 (UMLS CUI [1])
Platelet count (absolute)
Item
Platelet count (absolute)
text
C0032181 (UMLS CUI [1])
White blood cell count (WBC) (Absolute)
Item
White blood cell count (WBC) (Absolute)
text
C0023508 (UMLS CUI [1])
Neutrophil count (absolute)
Item
Neutrophil count (absolute)
text
C0948762 (UMLS CUI [1])
Lymphocyte count (absolute)
Item
Lymphocyte count (absolute)
text
C3544087 (UMLS CUI [1])
Monocyte count (absolute)
Item
Monocyte count (absolute)
text
C0200637 (UMLS CUI [1])
Eosinophil count (absolute)
Item
Eosinophil count (absolute)
text
C0200638 (UMLS CUI [1])
Basophil count (absolute)
Item
Basophil count (absolute)
text
C0200641 (UMLS CUI [1])
Item Group
Local Laboratory - Clinical Chemistry
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Lab ID
Item
Lab ID
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken clinical chemistry
date
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Time Sample Taken
Item
Time Sample Taken Clinical Chemistry
time
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Planned Relative Time Clinical Chemistry
integer
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Planned Relative Time Haematology
Code List
Planned Relative Time Clinical Chemistry
CL Item
Check-in (Result 1) (1)
CL Item
24 hours post-dose (Result 2) (2)
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Glucose (fasting)
Item
Glucose (fasting)
float
C0583513 (UMLS CUI [1])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
Serum Creatinine
Item
Serum Creatinine
float
C0201976 (UMLS CUI [1])
BUN
Item
Blood Urea Nitrogen
float
C0005845 (UMLS CUI [1])
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Creatine Phosphokinase (CPK)
Item
Creatine Phosphokinase (CPK)
float
C0201973 (UMLS CUI [1])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
fasting status
Item
Did the subject fast for 10 hours prior to dosing?
boolean
C0015663 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
correct treatment
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
reason correct treatment not recieved
Item
If No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item
Investigational Product
integer
C0304229 (UMLS CUI [1])
Investigational Product
Code List
Investigational Product
CL Item
Bottle A (small tablet #1) (1)
CL Item
Bottle B (small tablet #2) (2)
CL Item
Bottle C (large tablet) (3)
Date of Dose
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Dose
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
float
C2348070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Pharmacokinetics - Blood
C0031328 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
Item
Planned Relative Time, check one
integer
C0439564 (UMLS CUI [1])
C0005834 (UMLS CUI [2])
Planned Relative Time
Code List
Planned Relative Time, check one
CL Item
Pre-dose (1)
CL Item
+0.25 hrs (2)
CL Item
+0.5 hrs (3)
CL Item
+0.75 hrs (4)
CL Item
+1 hr (5)
CL Item
+1.5 hrs (6)
CL Item
+2 hrs (7)
CL Item
+2.5 hrs (8)
CL Item
+3 hrs (9)
CL Item
+4 hrs (10)
CL Item
+6 hrs (11)
CL Item
+8 hrs (12)
CL Item
+10 hrs (13)
CL Item
+12 hrs (14)
CL Item
+16 hrs (15)
CL Item
+24 hrs (16)
CL Item
+36 hrs (17)
CL Item
+48 hrs (19)
Date Blood Sample Taken
Item
Date Blood Sample Taken
date
C0005834 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Time Blood Sample Taken
Item
Time Blood Sample Taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Aliquot sample taken
Item
2 mL Aliquot, check if taken
boolean
C1277698 (UMLS CUI [1,1])
C1510844 (UMLS CUI [1,2])
Sample Number
Item
Sample Number
integer
C1299222 (UMLS CUI [1])
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