Healthy
Conditions
Brief summary
* 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.
Interventions
DRUGMetformin HCl
Sponsors
Torrent Pharmaceuticals Limited
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Countries
United States
Outcome results
None listed