NCT01283061

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

An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioavailability Study Of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of 'ACCOLATE' Tablets 20 mg of Astrazeneca Pharmaceuticals, USA In Healthy Adult Human Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

open label, randomized, two-period, two treatment, two sequence, crossover, balanced single dose comparative oral bioavailability study in healthy, adult, human subjects under fasting conditions.44 healthy, adult, human subjects.There was 11-day interval between treatments.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Zafirlukast	Zafirlukast tablets 20 mg

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2011-01-25
• Last updated: 2011-01-26

Locations

1 site across 1 country: India