Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fed, Healthy, Adult Subjects

NCT ID: NCT00944346

Last Updated: 2009-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL

Brief Summary

• Objective:

• A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects.
• Study Design:

• Randomized,single-dose,2-way crossover.

Conditions

Healthy

Interventions

Metformin HCl

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject is at least 18 years old.
• Subject had no clinically significant abnormal lab values at the screening evaluation.
• Subject's drugs of abuse, Hepatitis B, Hepatitis C, and HIV screenings were negative or non-relative.
• Acceptable screening of ECG.
• Female subject's pregnancy test at screening is negative.
• Subject had no evidence of underlying disease at the pre-entry physical examination.
• Subject has given written consent to participate.
• Female subject has not received any injectable or implantable contraceptive for a period of six months preceding this study.
• Agreed to undergo at least a 14-day pre-dose washout.
• Beginning two weeks prior to dosing and throughout the study, female subject of childbearing potential agrees to utilize one of the following methods of contraception:

1. Condom and topical spermicide

2. Condom and diaphragm

3. Intra-uterine device (I.U.D)

4. Complete abstinence.

• Agree to abstain from consuming caffeine or alcohol for at least 48 hours. prior to study and throughout the blood collection periods.

Exclusion Criteria

• History of treatment for alcoholism, substance abuse, or drug abuse with in the past 24 months.
• History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
• History of GRD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease.
• History of treatment for asthma, hypoxemia, dehydration, sepsis, metabolic acidosis and congestive heart failure.
• Subject is pregnant or lactating.
• History of drug hyper sensitivity.
• Subject was treated with any investigational drug during the four weeks prior to initial dosing for the study.
• Subject smokes more then 15 cigarettes per day or uses tobacco products or currently uses nicotine products.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Torrent Pharmaceuticals Limited

INDUSTRY

Sponsor Role: lead

Locations

Gateway Medical Research, Inc.

Saint Charles, Missouri, United States

Countries

United States

Other Identifiers

40484

Identifier Type: -

Identifier Source: org_study_id