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Bioequivalence Study of Cyclosporine 100mg Capsule Under Fasting Condition

NCT01080560 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2010-03-04

No results posted yet for this study

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 36 healthy adult male subjects under fasting condition.

Conditions

  • Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • Panacea Biotec Ltd

    lead INDUSTRY

Principal Investigators

  • Dr Nirav Gandhi · Accutest Research Laboratories (I) Pvt. Ltd.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2007-09-30
Completion
2007-10-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01080560 on ClinicalTrials.gov