ID

33263

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 informations about the blood sampling for pharmakokinetics and metabolites. It should be filled out at each visit if a blood sample for pharmacogenetics and metabolites has 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 (4)
  1. 12/3/18 12/3/18 -
  2. 12/19/18 12/19/18 -
  3. 12/19/18 12/19/18 -
  4. 12/21/18 12/21/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

December 3, 2018

DOI

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License

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

English

Blood Sampling for PK and Metabolites

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
Dose Time
Description

Dose Time

Data type

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
Blood Sample for PK and metabolites
Description

Blood Sample for PK and metabolites

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0031327
UMLS CUI-3
C0870883
Study Day
Description

Study Day

Data type

integer

Protocol Time
Description

Protocol Time

Data type

text

Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Time Deviation
Description

e.g. +2 min

Data type

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1705236
Reason for Deviation
Description

enter one code only: 1 = Slow/blocked cannula 2 = poor veins/difficult venepuncture 3 = subject not in attendance 4 = Other (enter comment)

Data type

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1705236
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Sample Number
Description

Sample Number

Data type

text

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
Conclusion
Description

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Description

Staff initials

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Blood Sampling for PK and Metabolites

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])
Dose Time
Item
Dose Time
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Blood Sample for PK and metabolites
C0005834 (UMLS CUI-1)
C0031327 (UMLS CUI-2)
C0870883 (UMLS CUI-3)
Item
Study Day
integer
Study Day
Code List
Study Day
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
10 (8)
Item
Protocol Time
text
Protocol Time
Code List
Protocol Time
CL Item
Pre Dose (Pre Dose)
CL Item
0h30 post dose (0h30 post dose)
CL Item
1h00 post dose (1h00 post dose)
CL Item
1h30 post dose (1h30 post dose)
CL Item
2h00 post dose (2h00 post dose)
CL Item
4h00 post dose (4h00 post dose)
CL Item
6h00 post dose (6h00 post dose)
CL Item
12h00 post dose (12h00 post dose)
CL Item
24h00 post dose (24h00 post dose)
CL Item
48h00 post dose (48h00 post dose)
CL Item
72h00 post dose (72h00 post dose)
CL Item
120h00 post dose (120h00 post dose)
CL Item
144h00 post dose (144h00 post dose)
CL Item
216h00 post dose (216h00 post dose)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Time Deviation
Item
Time Deviation
text
C0040223 (UMLS CUI [1,1])
C1705236 (UMLS CUI [1,2])
Item
Reason for Deviation
integer
C0392360 (UMLS CUI [1,1])
C1705236 (UMLS CUI [1,2])
Reason for Deviation
Code List
Reason for Deviation
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item
Sample Number
text
Sample Number
Code List
Sample Number
CL Item
101 (101)
CL Item
102 (102)
CL Item
103 (103)
CL Item
104 (104)
CL Item
105 (105)
CL Item
106 (106)
CL Item
107 (107)
CL Item
108 (108)
CL Item
109 (109)
CL Item
110 (110)
CL Item
111 (111)
CL Item
112 (112)
CL Item
113 (113)
CL Item
114 (114)
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])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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