Bioequivalence Study of Cyclosporine 100mg Capsule Under Fed Condition

NCT01080586 | Completed

• 1 other identifier: US/AHD/07/014
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Bioequivalence study in healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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

  upto 3 days

Secondary Outcomes (1)

• To monitor the safety and tolerability of single dose of cyclosporine in subjects

  upto 3 months

Study Arms (2)

NEORAL® Capsule 100 mg

ACTIVE COMPARATOR

Drug: Cyclosporine Capsules USP (Modified) 100 mg

Cyclosporine 100 mg Capsule

EXPERIMENTAL

Drug: Cyclosporine Capsules USP (Modified) 100 mg

Interventions

Cyclosporine Capsules USP (Modified) 100 mg DRUG

Subjects will be administered either Test Product or Reference Product with 240ml of water according to randomization schedule

Also known as: Cyclosporine Capsule, Gengraf Capsule, Sandimmune Capsule

Cyclosporine 100 mg Capsule; NEORAL® Capsule 100 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male subjects in the range of 18 - 45 years of age.
• 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).
• Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate and body temperature).
• Subjects with normal findings as determined by hematological tests, Serum Chemistry, serological tests, urine analysis, ECG and X-ray (X-ray if taken).
• Willingness to follow the protocol requirement as evidenced by written, informed consent.
• 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.
• No history or presence of significant alcoholism or drug abuse in the past one year.
• 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.

You may not qualify if:

• Requiring medication for any ailment including enzyme-modifying drugs in the previous 28 days, before day one (1).
• Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
• History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic or psychiatric diseases.
• Subjects with history of recent myocardial infarction, cardiac arrhythmias, cardiac failure and convulsions.
• Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
• History of malignancy or other serious diseases.
• 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.
• 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.
• Any contraindication with blood sampling.
• Refusal to abstain from smoking or consumption of tobacco products 48.00 hours before dosing until last sample collection of each period.
• Found positive in Breath alcohol test done at the time of check in for each study period.
• History of drug abuse in the past one year.
• Use of xanthine-containing beverages or food, and grape fruit juice for 48.00 hours prior to each drug dose.
• Blood donation 90 days prior to the commencement of the study.
• Subjects with positive HBsAg or Hepatitis-C tests or HIV tests or Anti Treponema Palladium/Syphilis test.

Sponsors & Collaborators

• Panacea Biotec Ltd: lead

Study Sites (1)

Accutest Research Laboratories (I) Pvt Ltd.

Ahmedabad, Gujarat, 380015, India

Location

MeSH Terms

Interventions

Cyclosporine; Cyclosporins

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dr Nirav Gandhi

  Accutest Research Laboratories (I) Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 4, 2010
• Study Start: September 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: October 1, 2007
• Last Updated: March 4, 2010

Record last verified: 2010-03

Locations

IN (1)