ID

33266

Beschrijving

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 any unscheduled blood sampling for pharmakokinetics. It should be filled out at follow up visit. It should be filled out at each visit, if any unscheduled blood samples for pharmacogenetics 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

Trefwoorden

Versies (3)
  1. 03-12-18 03-12-18 -
  2. 19-12-18 19-12-18 -
  3. 09-01-19 09-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

3 december 2018

DOI

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Licentie

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

Engels

Unscheduled Blood Sampling for PK

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschrijving

Subject Screening No.

Datatype

integer

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

Subject Number

Datatype

integer

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

Unscheduled Blood Sampling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C3854240
Blood Sample for PK and metabolites
Beschrijving

Blood Sample for PK and metabolites

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0031327
UMLS CUI-3
C0870883
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Time
Beschrijving

Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Reason for Deviation
Beschrijving

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

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C3854240
UMLS CUI [1,3]
C0200345
Sample Number
Beschrijving

Sample Number

Datatype

text

PK sample type number
Beschrijving

PK sample type number

Datatype

integer

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

Clinical Staff Initials

Datatype

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0871685
Conclusion
Beschrijving

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Beschrijving

Staff initials

Datatype

text

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

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Unscheduled Blood Sampling for PK

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Item Group
Blood Sample for PK and metabolites
C0005834 (UMLS CUI-1)
C0031327 (UMLS CUI-2)
C0870883 (UMLS CUI-3)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Reason for Unscheduled Sample
Item
Reason for Deviation
text
C0392360 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Sample Number
Item
Sample Number
text
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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