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Sponsored by: |
Teva Pharmaceuticals USA |
---|---|
Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00835497 |
This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical Industries, Ltd., and distributed by TEVA Pharmaceuticals USA with that of 5 mg/500 mg METAGLIP™ Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500 mg tablet) in healthy adult subjects administered under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: 5 mg/500 mg Glipizide Metformin Hydrochloride Tablets Drug: 5 mg/500 mg METAGLIP™ Tablets |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Relative Bioavailability Study of 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets Under Fasting Conditions. |
Enrollment: | 40 |
Study Start Date: | June 2004 |
Study Completion Date: | June 2004 |
Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: 5 mg/500 mg Glipizide Metformin Hydrochloride Tablets
1 x 5 mg/500 mg, single-dose fasting
|
2: Active Comparator |
Drug: 5 mg/500 mg METAGLIP™ Tablets
1 x 5 mg/500 mg, single-dose fasting
|
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
The subject's body mass index (BMI) should be less than or equal to 30.
The screening clinical laboratory procedures will include:
If female and:
Exclusion Criteria:
United States, Minnesota | |
PRACS Institute Ltd. | |
East Grand Forks, Minnesota, United States, 56721 | |
United States, North Dakota | |
PRACS Institute, Ltd. | |
Fargo, North Dakota, United States, 58104 |
Principal Investigator: | James D. Carlson, Pharm.D. | PRACS Institute, Ltd. |
Study ID Numbers: | R04-0476 |
Study First Received: | January 30, 2009 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00835497 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalene Healthy Subjects |
Hypoglycemic Agents Glipizide Metformin Healthy |
Hypoglycemic Agents Glipizide Physiological Effects of Drugs Metformin Pharmacologic Actions |