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

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944346
• Other study ID #: 40484
• Status: Completed
• Phase: Phase 1
• First received: July 21, 2009
• Last updated: July 22, 2009

Study information

• Verified date: July 2009
• Source: Torrent Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Metformin HCl

Locations

Country	Name	City	State
United States	Gateway Medical Research, Inc.	St, Charles	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Torrent Pharmaceuticals Limited

Country where clinical trial is conducted

United States,