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

• 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Metformin HCl

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St, Charles, Missouri, United States
      • Gateway Medical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Torrent Pharmaceuticals Limited

Study record dates

Study Registration Dates

• First Submitted: July 21, 2009
• First Submitted That Met QC Criteria: July 22, 2009
• First Posted (Estimate): July 23, 2009

Study Record Updates

• Last Update Posted (Estimate): July 23, 2009
• Last Update Submitted That Met QC Criteria: July 22, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: 40484