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OpenTrials
Completed

NCT Number: NCT00944346

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.

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Gateway Medical Research, Inc.

Saint Charles, Missouri, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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:
  • Condom and topical spermicide
  • Condom and diaphragm
  • Intra-uterine device (I.U.D)
  • 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.

Treatment and study plan

metformin HCl

Drug

Sponsors and collaborators

Lead sponsor

Torrent Pharmaceuticals Limited

Industry

Registry information

Important dates

First posted
Jul 23, 2009
Registry last updated
Jul 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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