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Bioequivalence Study of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition

NCT01283061 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2011-01-26

No results posted yet for this study

Summary

The objective of this study was to compare the relative bioavailability of zafirlukast tablets 20 mg with that of 'ACCOLATE®' tablets 20 mg (zafirlukast tablets 20 mg) in healthy, adult, human, subjects under fasting conditions and to monitor safety of subjects.

Conditions

  • Healthy

Interventions

DRUG

Zafirlukast

Zafirlukast tablets 20 mg

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Ronak Modi, MBBS · BA Research India Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-01-31
Completion
2008-01-31

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 NCT01283061 on ClinicalTrials.gov