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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00549263 |
Purpose
This study will test whether the Drug levels in plasma after combination formulation tablet dosing (SB797620) and separate formulation tablets dosing (rosiglitazone and glimepiride) to Japanese Healthy volunteer would be the same or not.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Subjects |
Drug: SB797620 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Bioequivalence Study With a Combination Tablet Formulation of Rosiglitazone (RSG) and Glimepiride (GLIM)(4mg/2mg) Compared to Concomitant Dosing of RSG 4mg Tablet and GLIM 1mg Commercial Tablet x 2 (4mg+2mg) in Japanese Healthy Male Subjects |
| Enrollment: | 0 |
| Study Start Date: | February 2008 |
Eligibility| Ages Eligible for Study: | 20 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00549263 History of Changes |
| Other Study ID Numbers: | AVR110549 |
| Study First Received: | October 23, 2007 |
| Last Updated: | June 12, 2008 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
Pharmacokinetics Bioequivalence Safety |