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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649948 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 500 mg (1 x 500 mg) dose administered under fed conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Metformin Hydrochloride ER Tablets 500 mg Drug: Glucophage XR 500 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Single-Dose Food In Vivo Bioequivalence Study Metformin Hydrochloride ER Tablets (500 mg; Mylan) and Glucophage® XR (500 mg; Bristol-Myers Squibb) in Healthy Volunteers |
| Enrollment: | 27 |
| Study Start Date: | February 2004 |
| Study Completion Date: | June 2004 |
| Primary Completion Date: | May 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Metformin Hydrochloride ER Tablets 500 mg
|
Drug: Metformin Hydrochloride ER Tablets 500 mg
500mg, single dose fed
|
|
Active Comparator: 2
Glucophage XR 500 mg
|
Drug: Glucophage XR 500 mg
500mg, single dose fed
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and non-pregnant, non-lactating female.
Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormone replacement therapy are permitted in this study. Acceptable forms of contraception include the following:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
Contacts and Locations| United States, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Principal Investigator: | Dorian Williams, M.D. | Kendle International Inc. |
More Information
| Responsible Party: | Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc. |
| ClinicalTrials.gov Identifier: | NCT00649948 History of Changes |
| Other Study ID Numbers: | METF-0413 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |