ID

33969

Description

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 about any unscheduled blood sampling for pharmakokinetics. It should be filled out at each visit, if any unscheduled blood samples for pharmacokinetics had been taken. 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

Keywords

Versions (3)
  1. 12/3/18 12/3/18 -
  2. 12/19/18 12/19/18 -
  3. 1/9/19 1/9/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 9, 2019

DOI

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License

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

English

Unscheduled Blood Sampling for PK

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Description

Subject Screening No.

Data type

integer

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

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Were any unscheduled blood sampling for PK conducted?
Description

Unscheduled Blood Sampling

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C3854240
Staff initials
Description

Staff initials

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Unscheduled Blood Sampling for PK
Description

Unscheduled Blood Sampling for PK

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C3854240
UMLS CUI-3
C0031327
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Description

Sample Number

Data type

text

Alias
UMLS CUI [1]
C1299222
PK sample type number
Description

PK sample type number

Data type

integer

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C1299222
Clinical Staff Initials
Description

Clinical Staff Initials

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0871685
Reason for Unscheduled Sample
Description

Reason for Unscheduled Sample

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C3854240
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Similar models

Unscheduled Blood Sampling for PK

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Unscheduled Blood Sampling
Item
Were any unscheduled blood sampling for PK conducted?
boolean
C0005834 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Item Group
Unscheduled Blood Sampling for PK
C0005834 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C0031327 (UMLS CUI-3)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Sample Number
Item
Sample Number
text
C1299222 (UMLS CUI [1])
Item
PK sample type number
integer
C0201734 (UMLS CUI [1,1])
C1299222 (UMLS CUI [1,2])
PK sample type number
Code List
PK sample type number
CL Item
1 (1)
Clinical Staff Initials
Item
Clinical Staff Initials
text
C2986440 (UMLS CUI [1,1])
C0871685 (UMLS CUI [1,2])
Reason for Unscheduled Sample
Item
Reason for Unscheduled Sample
text
C0392360 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,3])
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