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Bioequivalence Study of Tacrolimus 1 mg Capsule Under Fasting Condition

NCT01080456 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2010-03-04

No results posted yet for this study

Summary

The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 1 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus) Capsules 1 mg, manufactured by Astellas Pharma, Inc., USA in 36 normal, healthy, adult, male subjects under fasting condition.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Tacrolimus 1 mg capsule

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

Sponsors & Collaborators

  • Panacea Biotec Ltd

    lead INDUSTRY

Principal Investigators

  • Dr. Suhas Khandave · Accutest Research Laboratories (I) Pvt. Ltd.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2007-10-31
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 NCT01080456 on ClinicalTrials.gov