NCT01691469

Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fed Condition

An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fed Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.

Detailed description

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Montelukast Sodium Oral Granules 4mg of Dr. Reddy's Laboratories Limited, India comparing with that of SINGULAIR® (Montelukast sodium) 4mg oral granules of Merck Sharp \& Dohme Ltd., USA in healthy, adult, human subjects under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Montelukast sodium	Montelukast Sodium Oral Granules 4mg

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-01-01
• Completion: 2011-02-01
• First posted: 2012-09-24
• Last updated: 2012-09-24

Locations

1 site across 1 country: India