Bioequivalence Study of Cetapin-XR, 500 mg of Sanofi India Ltd. with GLUCOPHAGE® XR, 500 mg of Bristol-Myers Squibb Company in Normal, Healthy, Adult Male and Female Subjects under fasting and Fed Conditions
- Registration Number
- CTRI/2018/04/012998
- Lead Sponsor
- Sanofi India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 56
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??
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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate the bioequivalence between <br/ ><br>Test Product: Cetapin-XR (as Metformin Hydrochloride) Sustained <br/ ><br>Release Tablets, 500 mg of Sanofi India Ltd. with Reference <br/ ><br>Product: GLUCOPHAGE® XR (Metformin Hydrochloride) <br/ ><br>Extended-Release Tablets, 500 mg of Bristol-Myers Squibb <br/ ><br>Company Princeton, NJ 08543 USA in normal, healthy, adult male <br/ ><br>and female subjects under Fed and fasting conditions.Timepoint: Cmax AUC0-t and AUC0-inf <br/ ><br>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 Outcome Measures
Name Time Method To monitor the safety and tolerability of a <br/ ><br>single dose of Metformin hydrochloride sustained release tablets, <br/ ><br>500 mg in normal, healthy adult male and female subjects.Timepoint: AUC0-t/AUC0-inf, Tmax, Kel and t1/2 <br/ ><br>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