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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00500201 |
Study to compare PK of a new 120mg tablet with two 60mg tablets. This is required because we plan to have only single tablets administered in the later phase clinical trials but we have not had a 120mg strength before. As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 2x60mg before we start a large manufacturing campaign and before we administer to a large number of patients. The study is planned to consist of a single part, with two dosing periods, periods 1 and 2 consisting of 18 subjects. There will be 20 days washout between each dose. Initially 4 subjects will be given a single oral dose of 120 mg SB-773812 and 2 will be given placebo. If 120mg SB-773812 is well tolerated in the first four volunteers, the remaining 12 subjects will be dosed. If the 120mg single oral dose in the first 4 subjects is poorly tolerated, the study will be stopped. Subjects will return to the centre for follow-up 14 to 21 days after the final dose.It is expected that the total duration of the study should be approximately 11 weeks.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: SB- 773812 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Crossover Assignment, Bio-availability Study |
Official Title: | A Single Blind, Double Dummy, Placebo Controlled, Randomized, 2 Period Crossover Study to Assess the Relative Bioavailability of a 120mg Tablet Compared to Two 60 mg SB-773812 Tablets in Healthy Volunteers |
Enrollment: | 18 |
Study Start Date: | May 2007 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | NAA105737 |
Study First Received: | July 10, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00500201 |
Health Authority: | United Kingdom: Research Ethics Committee |
Healthy Volunteer |
Schizophrenia Mental Disorders Psychotic Disorders Healthy Schizophrenia and Disorders with Psychotic Features |