NCT02322658

Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fed Conditions

An Open Label, Balanced, Randomized, Two-Treatment, Two Period, Two-Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Eszopiclone Tablets 3 mg of Dr. Reddy's Laboratories Limited, and 'LUNESTA' Tablets 3 mg, Mfg For Sepracor Inc. USA In Healthy Adult Human Subjects Under Fed Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fed conditions.

Detailed description

An open label, balanced, randomized, two-treatment, two-period, two-sequence,single dose, crossover, oral bioequivalence study of Eszopiclone tablets 3 mg of Dr. Reddy's Laboratories limited, and 'LUNESTA' tablets 3 mg Mfg for Sepracor Inc. USA in healthy adult human subjects under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Eszopiclone Tablets 3 mg

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-09-01
• Completion: 2008-10-01
• First posted: 2014-12-23
• Last updated: 2014-12-23

Locations

1 site across 1 country: India