ID

33431

Descripción

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

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Versiones (3)

1. 1/12/18 1/12/18 -
2. 8/12/18 8/12/18 -
3. 18/12/18 18/12/18 - Sarah Riepenhausen

Titular de derechos de autor

GlaxoSmithKline

Subido en

8 de diciembre de 2018

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