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Sponsored by: |
Ranbaxy Laboratories Limited |
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Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00778791 |
The objective of this study is to compare the relative bioavailability of metformin HC1 750 mg extended-release tablets (Ranbaxy) with that of Glucophage® XR 750 mg tablets (Bristol Myers Squibb) in healthy, adult, subjects under fasting conditions.
Condition | Intervention |
---|---|
Healthy |
Drug: metformin HC1 750 mg extended-release tablets |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | The Objective of This Study is to Compare the Relative Bioavailability of Metformin HC1 750 mg Extended-Release Tablets (Ranbaxy) With That of Glucophage® XR 750 mg Tablets (Bristol Myers Squibb) in Healthy, Adult, Subjects Under Fasting Conditions. |
Enrollment: | 60 |
Study Start Date: | April 2004 |
Study Completion Date: | July 2004 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
metformin HC1 750 mg extended-release tablets
|
Drug: metformin HC1 750 mg extended-release tablets |
2: Experimental
Glucophage® XR 750 mg tablets
|
Drug: metformin HC1 750 mg extended-release tablets |
This study was randomised, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study planned on 60 healthy, adult, subjects under fasting conditions. 60 subjects were enrolled and 55 subjects completed all the periods of the study. Both periods were separated by a washout period of fourteen days A total of Sixty (60) subjects were enrolled in this study; 55 completed the study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Ranbaxy Research Labs ( Dr. Tausif Monif ) |
Study ID Numbers: | B045502 |
Study First Received: | October 22, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00778791 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence metformin HC1 750 mg extended-release tablets |
Hypoglycemic Agents Metformin Healthy |
Hypoglycemic Agents Physiological Effects of Drugs Metformin Pharmacologic Actions |