NCT00649636

Fasting Study of Fluoxetine Capsules 40 mg and Prozac Pulvules 40 mg

Single-Dose Fasting Bioequivalence Study of Fluoxetine Capsules (40 mg; Mylan) and Prozac Pulvules (40 mg; Dista) in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to investigate the bioequivalence of Mylan's fluoxetine hydrochloride 40 mg capsules to Dista's Prozac 40 mg pulvules following a single, oral 40 mg (1 x 40 mg) dose administration under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Fluoxetine Capsules 40 mg	40mg, single dose fasting
DRUG	Prozac Pulvules 40 mg	40mg, single dose fasting

Timeline

• Start date: 2006-02-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States