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

This study has been completed.
Sponsor:
Information provided by:
Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT00944177
First received: July 21, 2009
Last updated: July 22, 2009
Last verified: July 2009
  Purpose
  • 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.

Condition Intervention Phase
Healthy
Drug: Metformin HCl
Phase 1

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Torrent Pharmaceuticals Limited:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944177

Locations
United States, Missouri
Gateway Medical Research, Inc.
St, Charles, Missouri, United States
Sponsors and Collaborators
Torrent Pharmaceuticals Limited
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00944177     History of Changes
Other Study ID Numbers: 40483
Study First Received: July 21, 2009
Last Updated: July 22, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014