ID
33431
Beskrivning
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 subjects dietary status and physical activity. It should be filled out at the screening visit. Dietary Restricions: Subjects not to consume the following foodstuffs for five days prior to and including each dosing day:- - Grapfruit, Grapefruit juice and grapefruit containing products - Quinine – containing products - Broccoli - Brussel sprouts - Watercress - Cabbage (incl. Coleslaw) - Charcoal broiled beef Subjects will refrain from consuming caffeinated beverages for 48 hours prior to and including each dosing day Subjects must refrain from strenuous exercise for 48 hours before the screening medical examination and for the entire duration of the study 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
Nyckelord
Versioner (3)
- 2018-12-01 2018-12-01 -
- 2018-12-08 2018-12-08 -
- 2018-12-18 2018-12-18 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
8 december 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434
Dietary Status and Physical Activity
- StudyEvent: ODM
Beskrivning
Dietary Status and Physical Activity
Alias
- UMLS CUI-1
- C0392209
- UMLS CUI-2
- C0026606
Beskrivning
If Yes, exclude
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0042441
- UMLS CUI [2]
- C2987738
Beskrivning
If yes, detail below
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0425422
- UMLS CUI [1,2]
- C0205476
Beskrivning
If subject has any medical dietary restrictions
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0425422
- UMLS CUI [1,2]
- C0205476
- UMLS CUI [1,3]
- C2348235
Beskrivning
Subject Caffeine Consumption
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0948365
Beskrivning
If the subject consumes caffeine UPPER LIMIT OF CAFFEINE IS 6 CUPS PER DAY
Datatyp
integer
Måttenheter
- cups/day
Alias
- UMLS CUI [1,1]
- C0948365
- UMLS CUI [1,2]
- C2164136
Beskrivning
If Yes, complete below
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0679823
- UMLS CUI [1,2]
- C0015259
Beskrivning
If subject participates in any exercise
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0015259
- UMLS CUI [1,2]
- C0332307
Beskrivning
No. of Exercise Sessions per Week
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015259
- UMLS CUI [1,2]
- C0585296
Beskrivning
Conclusion
Alias
- UMLS CUI-1
- C1707478
Similar models
Dietary Status and Physical Activity
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0026606 (UMLS CUI-2)
C2987738 (UMLS CUI [2])
C0205476 (UMLS CUI [1,2])
C0205476 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C2164136 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0585296 (UMLS CUI [1,2])
C1552089 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,2])