None listed
Conditions
Interventions
Intervention1: Cetapin-XR (as Metformin Hydrochloride) Sustained Release Tablets: Sustained Release Tablets
Control Intervention1: GLUCOPHAGE® XR
(Metformin Hydrochloride) Extended-Release Tablets, 5
Sponsors
Sanofi India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and non pregnant female human subjects, age in the range of 18 â?? 45 years. 2. Body Mass Index between 18.5-24.9 Kg / m2 extremes included. 3.Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and axillary temperature). 4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urinalysis, 12 lead ECG and chest X-ray (if done). 5. Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and tobacco products for 48 hours prior to dosing until after the last blood sample collection in each study period and adherence to food, fluid and posture restrictions. 6. No history of significant alcoholism. 7. No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs (Appendix B) for the last 6 months. 8. Non-smokers, ex-smokers and moderate smokers will be included. â??Moderate smokers are defined as someone smoking 10 cigarettes or less per day, ex-smokers are someone who completely stopped smoking for at least 3 months.â??
Exclusion criteria
Exclusion criteria: 1. Known history of hypersensitivity to Metformin hydrochloride or related drugs. 2. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day. 3. Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of Investigational Product. 4. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, bloodâ??forming organs etc. 5. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases. 6. Participation in a clinical drug study or bioequivalence study 90 days prior to period I dosing of the present study. 7. History of malignancy or other serious diseases. 8. Blood donation 90 days prior to period I dosing of the present study. 9. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests. 10. Found positive in breath alcohol test. 11. Found positive in urine test for drug abuse. 12. History of problem in swallowing. 13. Any contraindication to blood sampling. 14. Found positive serum (β) Beta- hCG (Human Chorionic Gonadotropin) test. 15. Lactating women (currently breast feeding). 16. Female subjects not confirming to using birth control measures, from the date of screening until the completion of the study. (Note: Abstinence, barrier methods e.g. condom, diaphragm, etc. are acceptable.) 17. Use of hormonal contraceptives either oral or implants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the bioequivalence between Test Product: Cetapin-XR (as Metformin Hydrochloride) Sustained Release Tablets, 500 mg of Sanofi India Ltd. with Reference Product: GLUCOPHAGE® XR (Metformin Hydrochloride) Extended-Release Tablets, 500 mg of Bristol-Myers Squibb Company Princeton, NJ 08543 USA in normal, healthy, adult male and female subjects under Fed and fasting conditions.Timepoint: Cmax AUC0-t and AUC0-inf Sampling hrs: Pre dose (collected within 1.00 hr prior to dosing), 0.50, 1.00, 2.00, 3.00, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 9.00, 10.00, 11.00, 12.00, 16.00, 24.00 and 36.00 hrs post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of a single dose of Metformin hydrochloride sustained release tablets, 500 mg in normal, healthy adult male and female subjects.Timepoint: AUC0-t/AUC0-inf, Tmax, Kel and t1/2 Sampling hrs: Pre dose (collected within 1.00 hr prior to dosing), 0.50, 1.00, 2.00, 3.00, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 9.00, 10.00, 11.00, 12.00, 16.00, 24.00 and 36.00 hrs post dose | — |
Countries
India
Contacts
Public ContactAjit Walekar
Sanofi India Ltd.
Outcome results
None listed