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

Torrent Pharmaceuticals Limited2 个研究点分布在 1 个国家开始时间: 2009年7月23日最近更新: 2009年7月23日

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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.

•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.

•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.

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