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

Status:

COMPLETED

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

Lead Sponsor:

Torrent Pharmaceuticals Limited

Conditions:

Healthy

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 ...

Eligibility Criteria

Inclusion

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:
Condom and topical spermicide
Condom and diaphragm
Intra-uterine device (I.U.D)
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

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00944346

Last Update

July 23 2009

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