Bioequivalence Study of Metformin Hydrochloride 1000mg Tablets Under Fasting Conditions

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ranbaxy Laboratories Limited
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. Males and females, 18 to 60 years of age (inclusive).

2. A body mass index (BMI) of 18-30 kg/m2 inclusive as calculated according to Novum Standard Operating Procedures.

3. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.

4. Signed and dated informed consent form, which meets all criteria of current FDA regulations.

5. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable method of contraception (e.g. condom with spermicide, IUD, hormonal contraceptives) for at least 30 days prior to dosing and during the duration of the study.

Exclusion Criteria:

1. If female, pregnant, lactating or likely to become pregnant during the study.

2. History or allergy or sensitivity to metformin, other hyperglycemic agents, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.

3. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.

4. Presence of gastrointestinal disease or history of malabsorption within the last year.

5. History of psychiatric disorders occurring within the last two years that required hospitalization or medication.

6. Presence of a medical condition requiring regular treatment with prescription drugs.

7. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.

8. Receipt of any drug as part of a research study within 30 days prior to dosing.

9. Drug or alcohol addiction requiring treatment in the past 12 months.

10. Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.

11. Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody.

12. Positive test results for drug of abuse at screening.

13. Positive serum pregnancy test.