NCT02291367

Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting Condition

Single Dose Crossover Comparative Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg in Healthy Adult Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study were to compare the relative bioavailability of Duloxetine HCl delayed release capsule 60 mg with that of 'CYMBALTA®' delayed release capsule 60 mg (Duloxetine HCl delayed release capsule 60 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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Duloxetine	Duloxetine Delayed-Release Capsules 60 mg
DRUG	Cymbalta®	60 mg capsule of Eli Lilly and Company

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2014-11-14
• Last updated: 2014-11-14

Locations

1 site across 1 country: India