Overview

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 Subje

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Details
Lead Sponsor:
Torrent Pharmaceuticals Limited
Treatments:
Metformin
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.