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

Launched by TORRENT PHARMACEUTICALS LIMITED · Mar 17, 2010

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility criteria

• 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 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.