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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014