Type 2 Diabetes
Conditions
Brief summary
Objective: An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single- Dose Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 500 mg Tablet (Reference formulation, Bristol- Myers Squibb company, USA) in Healthy Volunteers under Fed Conditions. Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment, Crossover Study under fed condition.
Interventions
DRUGMetformin
Sponsors
Torrent Pharmaceuticals Limited
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Inclusion criteria
* The subjects who qualify for the study should meet the following inclusion criteria. 1. Male subjects in the range of 18 - 45 years of age. 2. Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart. 3. Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and body temperature) 4. Subjects with normal findings as determined by hematological tests, serum chemistry, urine analysis, ECG and X-ray. 5. Willingness to follow the protocol requirement as evidenced by written, informed consent. 6. Agreeing to, not using any medication (prescription and over the counter), including vitamins and minerals for two weeks prior to study & during the course of the study. 7. No history or presence of significant alcoholism or drug abuse in the past one year. 8. Non-smokers, ex smokers and light smokers will be included. Light smokers are defined as someone smoking 10 cigarettes or less per day, ex smokers as someone who completely stopped smoking for at least 3 months.
Exclusion criteria
* The subjects who qualify for the study should not meet the following
Countries
India
Outcome results
None listed