ID
33266
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 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
Mots-clés
Versions (3)
- 03/12/2018 03/12/2018 -
- 19/12/2018 19/12/2018 -
- 09/01/2019 09/01/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
3 décembre 2018
DOI
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Licence
Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold
Unscheduled Blood Sampling for PK
- StudyEvent: ODM
Description
Blood Sample for PK and metabolites
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031327
- UMLS CUI-3
- C0870883
Description
Date
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
Description
Time
Type de données
time
Alias
- UMLS CUI [1]
- C0040223
Description
enter one code only: 1 = Slow/blocked cannula 2 = poor veins/difficult venepuncture 3 = subject not in attendance 4 = Other (enter comment)
Type de données
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C3854240
- UMLS CUI [1,3]
- C0200345
Description
Sample Number
Type de données
text
Description
PK sample type number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C1299222
Description
Clinical Staff Initials
Type de données
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C0871685
Description
Conclusion
Alias
- UMLS CUI-1
- C1707478
Similar models
Unscheduled Blood Sampling for PK
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,2])
C0031327 (UMLS CUI-2)
C0870883 (UMLS CUI-3)
C3854240 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C1299222 (UMLS CUI [1,2])
C0871685 (UMLS CUI [1,2])
C1552089 (UMLS CUI [1,2])