NCT01674504

Bioequivalence Study of Montelukast Sodium Chewable Tablets 4mg and 5mg Under Fasting Condition

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 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 chewable tablets 4mg and 5mg of Dr. Reddy's Laboratories Limited, India comparing with that of SINGULAIR® (containing Montelukast sodium) chewable tablets 4mg and 5 mg of Merck Sharp \& Dohme Ltd., USA in healthy, adult, human subjects under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Montelukast sodium chewable tablets 4 mg and 5 mg	Montelukast sodium chewable tablets 4mg and 5mg

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2012-08-29
• Last updated: 2012-08-29

Locations

1 site across 1 country: India