Bioequivalence Study of Cyclosporine 100mg Capsule Under Fed Condition

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

To demonstrate bioequivalence between Test Product (A):Cyclosporine Soft Gelatin Capsules Modified 100 mg manufactured by Panacea Biotec Ltd, India and the corresponding Reference Product (B):Neoral (Cyclosporine capsules,USP)Modified 100mg manufactured by Novartis Pharmaceuticals Corporation, New Jersey, in 78 healthy adult male subjects under fed condition.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Panacea Biotec Ltd
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

1. Male subjects in the range of 18 - 45 years of age.

2. The healthy human subjects, whose body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart (Appendix A).

3. Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate and body temperature).

4. Subjects with normal findings as determined by hematological tests, Serum Chemistry, serological tests, urine analysis, ECG and X-ray (X-ray if taken).

5. Willingness to follow the protocol requirement as evidenced by written, informed consent.

6. Agreeing to, not using any medication (either prescribed, OTC or alternate medicines), including vitamins and minerals for 14 days prior to study and 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:

1. Requiring medication for any ailment including enzyme-modifying drugs in the previous 28 days, before day one (1).

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. Subjects with history of recent myocardial infarction, cardiac arrhythmias, cardiac failure and convulsions.

5. Participation in a clinical drug study or bioequivalence study 90 days prior to present study.

6. History of malignancy or other serious diseases.

7. Refusal to abstain from food for at least ten (10.00) hours prior to drug administration and for at least four (04.00) hours post dose.

8. Refusal to abstain from water for at least one (01.00) hour prior to study drug administration on first day of each study period and for at least two (02.00) hours post dose.

9. Any contraindication with blood sampling.

10. Refusal to abstain from smoking or consumption of tobacco products 48.00 hours before dosing until last sample collection of each period.

11. Found positive in Breath alcohol test done at the time of check in for each study period.

12. History of drug abuse in the past one year.

13. Use of xanthine-containing beverages or food, and grape fruit juice for 48.00 hours prior to each drug dose.

14. Blood donation 90 days prior to the commencement of the study.

15. Subjects with positive HBsAg or Hepatitis-C tests or HIV tests or Anti Treponema Palladium/Syphilis test.

16. Known history of hypersensitivity to Cyclosporine or to any component of the formulation.

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