Bioequivalence Study of Cyclosporine 100mg Capsule Under Fasting Condition

This study has been completed.
Sponsor:
Information provided by:
Panacea Biotec Ltd
ClinicalTrials.gov Identifier:
NCT01080560
First received: March 2, 2010
Last updated: March 3, 2010
Last verified: March 2010
  Purpose

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 36 healthy adult male subjects under fasting condition.


Condition Intervention
Healthy Volunteers
Drug: Cyclosporine Capsules USP (Modified) 100 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Randomized Single Dose Open Label Bioequivalence Study of Cyclosporine Capsules USP (Modified)100mg in Normal Healthy Male Subjects Under Fasting Condition

Resource links provided by NLM:


Further study details as provided by Panacea Biotec Ltd:

Primary Outcome Measures:
  • To demonstrate bioequivalence between Test Product,Cyclosporine Soft Gelatin Capsules Modified 100mg of Panacea Biotec and the corresponding Reference Product, Neoral(Cyclosporine Capsule,USP)of Novartis Pharmaceutical Corporation, New Jersey [ Time Frame: upto 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To monitor the safety and tolerability in subjects receiving single dose of Cyclosporine Capsule. [ Time Frame: upto 3 months ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: August 2007
Study Completion Date: October 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NEORAL® Capsule 100 mg Drug: Cyclosporine Capsules USP (Modified) 100 mg
Subjects will be administered either Test Product or Reference Product with 240ml of water according to randomization schedule
Other Names:
  • Cyclosporine Capsule
  • Gengraf Capsule
  • Sandimmune Capsule
Experimental: Cyclosporine 100 mg Capsule Drug: Cyclosporine Capsules USP (Modified) 100 mg
Subjects will be administered either Test Product or Reference Product with 240ml of water according to randomization schedule
Other Names:
  • Cyclosporine Capsule
  • Gengraf Capsule
  • Sandimmune Capsule

Detailed Description:

Total 36 normal healthy adult male subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 240 mL of water in each period as per the randomization schedule. Subjects will fast for at least 10 hours prior to dose administration and for at least 4 hours post dose. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour Predose and 2 hours Post dose in each period. A total of 24 blood samples will be withdrawn for pharmacokinetic profiling. The whole blood concentrations of Cyclosporine will be measured by a validated LC/MS/MS analytical method. Ratio analysis will be performed for untransformed and log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0 inf. ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0-inf and 90% confidence interval will be constructed for the ratio of geometric least square mean of the Test and Reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval, both falls within the acceptable range of 80.00% to 125.00% for Cmax, AUC0-72 and AUC0-inf.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080560

Locations
India
Accutest Research Laboratories (I) Pvt Ltd.
Ahmedabad, Gujrat, India, 380015
Sponsors and Collaborators
Panacea Biotec Ltd
Investigators
Principal Investigator: Dr Nirav Gandhi Accutest Research Laboratories (I) Pvt. Ltd.
  More Information

No publications provided

Responsible Party: Dr. Arani Chatterjee, Panacea Biotec Ltd
ClinicalTrials.gov Identifier: NCT01080560     History of Changes
Other Study ID Numbers: US/AHD/07/013
Study First Received: March 2, 2010
Last Updated: March 3, 2010
Health Authority: United States: Institutional Review Board
India: Central Drugs Standard Control Organization

Keywords provided by Panacea Biotec Ltd:
Bioequivalence study in healthy volunteers

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 16, 2014