ID

33769

Descripción

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information concerning clinical laboratory safety tests of the subject. It should be filled out at the screening visit. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Palabras clave

Versiones (3)
  1. 1/12/18 1/12/18 -
  2. 11/12/18 11/12/18 -
  3. 25/12/18 25/12/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

25 de diciembre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Inglés

Clinical Laboratory Safety Tests

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Descripción

Subject Screening No.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Subject no.
Descripción

Subject Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Date Information Collected
Descripción

Date Information Collected

Tipo de datos

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008
Has the subject fasted?
Descripción

Fasting

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015663
Clinical Laboratory Safety Tests
Descripción

Clinical Laboratory Safety Tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005767
Time Blood Samples Taken
Descripción

Time Blood Samples Taken

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0040223
Clinical Chemistry Comments
Descripción

Clinical Chemistry Comments

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0947611
Haematology Comments
Descripción

Haematology Comments

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0947611
Hepatitis B and C and HIV I & II Comments
Descripción

HepB and C and HIV I & II Comments

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0947611
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0947611
UMLS CUI [3,1]
C0019682
UMLS CUI [3,2]
C0947611
Clinical Staff initials
Descripción

Clinical Staff initials

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0871685
Urine Tests
Descripción

Urine Tests

Alias
UMLS CUI-1
C0042036
UMLS CUI-2
C0022885
Time Urine Samples Taken
Descripción

Time Urine Samples Taken

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200354
Urinalysis Comments
Descripción

Urinalysis Comments

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0947611
Urine Microscopy Comments
Descripción

Urine Microscopy Comments

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0947611
Drugs of Abuse & Alcohol Screen Comments
Descripción

Drug Abuse and Alcohol Screen Comments

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0947611
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0947611
Clinical Staff initials
Descripción

Clinical Staff initials

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0871685
HIV I and II
Descripción

HIV I and II

Alias
UMLS CUI-1
C0019682
Date of Sample Collection
Descripción

Date of Sample Collection

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
HIV I & II negative
Descripción

HIV I & II Negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0481430
Physician's Initials
Descripción

Physician's Initials

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
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Similar models

Clinical Laboratory Safety Tests

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Date Information Collected
Item
Date Information Collected
date
C3244127 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Item Group
Clinical Laboratory Safety Tests
C0022885 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Time Blood Samples Taken
Item
Time Blood Samples Taken
time
C1277698 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Clinical Chemistry Comments
Item
Clinical Chemistry Comments
text
C0008000 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Haematology Comments
Item
Haematology Comments
text
C0018941 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
HepB and C and HIV I & II Comments
Item
Hepatitis B and C and HIV I & II Comments
text
C0019163 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
C0019682 (UMLS CUI [3,1])
C0947611 (UMLS CUI [3,2])
Clinical Staff initials
Item
Clinical Staff initials
text
C2986440 (UMLS CUI [1,1])
C0871685 (UMLS CUI [1,2])
Item Group
Urine Tests
C0042036 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Time Urine Samples Taken
Item
Time Urine Samples Taken
time
C0040223 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
Urinalysis Comments
Item
Urinalysis Comments
text
C0042014 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Urine Microscopy Comments
Item
Urine Microscopy Comments
text
C0430397 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Drug Abuse and Alcohol Screen Comments
Item
Drugs of Abuse & Alcohol Screen Comments
text
C0373483 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0001948 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
Clinical Staff initials
Item
Clinical Staff initials
text
C2986440 (UMLS CUI [1,1])
C0871685 (UMLS CUI [1,2])
Item Group
HIV I and II
C0019682 (UMLS CUI-1)
Date of Sample Collection
Item
Date of Sample Collection
date
C1302413 (UMLS CUI [1])
HIV I & II Negative
Item
HIV I & II negative
boolean
C0481430 (UMLS CUI [1])
Physician's Initials
Item
Physician's Initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
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