Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet Versus Glucophage XR® 500 mg Tablet in Healthy Volunteers Under Fed Conditions

Exclusion Criteria

• •1. Requiring medication for any ailment including enzyme-modifying drugs Use of any drugs known to induce or inhibit hepatic drug metabolism (e.g.s, inducers: barbiturates, carbazepine, phenytoin, glucocorticoids, omeprazole; inhibitors: selective serotonin reuptake inhibitors (SSRIs), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
• •2. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
• •3. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic or psychiatric diseases.
• •4. Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
• •5. History of malignancy or other serious diseases.
• •6. Refusal to abstain from food for ten (10) hours prior to study drug administration on first day of each study period and for four (4) additional hours each, post dose.
• •7. Refusal to abstain from water for one hour pre dose and for two (2) hours, post dosing.
• •8. Any contraindication to blood sampling.
• •9. Refusal to abstain from smoking or consumption of tobacco products 24 hours before dosing until last sample collection of each period. Habituation of tobacco necessitating uninterrupted tobacco consumption.
• •10. Use of xanthine-containing beverages or food for 48 hours prior to each drug dose.
• •11. Blood donation 90 days prior to the commencement of the study.
• •12. Subjects with positive HIV tests, HbsAg or Hepatitis-C tests.
• •13. Known history of allergic reactions to Metformin or other related drugs.
• •14. History of drug abuse in the past one year.
• •15. Use of prescription medication or over the counter products (including natural food supplements,vitamins, garlic as a supplement) within 2 weeks prior to administration of study medication, except for topical products without systemic absorption.