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Sponsored by: |
Ranbaxy Laboratories Limited |
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Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00778427 |
The objective of this study was to evaluate the relative bioavailability of the test formulation of metformin hydrochloride 1000 mg tablets with an already marketed reference formulation GLUCOPHAGE® (metformin hydrochloride) 1000 mg tablets (Bristol-Myers Squibb Company) under fasted conditions in healthy, male and female adult subjects.
Condition | Intervention |
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Healthy |
Drug: metformin hydrochloride 1000 mg tablets |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Study to Compare the Relative Bioavailability of Ranbaxy and Bristol Myers Squibb Formulations of Metformin 1000 mg Tablets in Healthy Adult Volunteers Under Fasting Conditions |
Enrollment: | 32 |
Study Start Date: | February 2006 |
Study Completion Date: | April 2006 |
Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
metformin hydrochloride 1000 mg tablets of Ranbaxy
|
Drug: metformin hydrochloride 1000 mg tablets |
2: Active Comparator
GLUCOPHAGE® (metformin hydrochloride) 1000 mg tablets
|
Drug: metformin hydrochloride 1000 mg tablets |
This randomized, single-dose, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 1000 mg metformin hydrochloride tablets under fasting conditions. The study was conducted with 32 (30 completing) healthy adults in accordance with Protocol No. 10640302 (Revision 0). In each study period, a single dose (1 x 1000 mg tablet) was administered to all subjects following an overnight fast of at least 10 hours. The test formulation was Ohm Laboratories, Inc's (A Group of Ranbaxy Pharmaceuticals Inc.) Metformin Hydrochloride 1000 mg Tablets and the reference formulation was GLUCOPHAGE® (metformin hydrochloride) 1000 mg Tablets (Bristol-Myers Squibb Company). The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments.
Blood samples were collected pre-dose and at intervals over 24 hours after each dose. The plasma samples for all subjects completing both periods of the study were sent to Helen Fassoulas, Director of Operations, Warnex Bioanalytical Services Inc., 3885 boul Industriel, Laval, Quebec, H7L4S3 Canada, Telephone: 450-663-6724, Fax: 450-975-8111 for determination of metformin concentrations.
Statistical analysis was performed by Braulio Suarez, M.D., Novum Pharmaceutical Research Services, Wilcrest Green Office Park, 3320 Walnut Bend Lane, Houston, Texas 77042-4712, USA, Telephone: 832-251-8100, Fax: 832-251-7133.
A total of 32 healthy adult subjects (30 completing).
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Ranbaxy research labs ( Dr. Tausif Monif ) |
Study ID Numbers: | 10640302 |
Study First Received: | October 22, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00778427 |
Health Authority: | United States: Institutional Review Board |
Bioequivalence metformin hydrochloride 1000 mg tablets fasting conditions |
Metformin Healthy |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |