NCT00778024

Bioequivalence Study of Fluoxetine HCL 40 mg Capsules Under Fasting Conditions

The Objective of This Randomized, Single-dose, Two-way Evaluation is to Compare the Bioequivalence of a Test Fluoxetine HCL Formulation (Ranbaxy Laboratories Limited, Lot No. 6320101) to an Equivalent Oral Dose of the Commercially Available Fluoxetine HCL (Prozac®, Dista Products Company, Lot No 6RK57M) in a Test Population of 36 Adult Subjects Under Fasting Conditions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the relative bioavailability of fluoxetine HCL 40 mg capsules (by Ranbaxy Laboratories Limited) with that of PROZAC® 40 mg capsules (by Dista Products Company) following a single oral dose (1 x 40 mg capsule) in healthy, adult subjects under fasting conditions

Detailed description

This is a single-dose, open-label, randomized two-way crossover study to evaluate the bioequivalence of a test formulation, versus an equivalent dose of a commercially available reference drug product, in 36 adult subjects, under fasted conditions. Drug administrations are separated by at least 49 days. Vital signs (sitting blood pressure and pulse rate) were obtained at baseline (Hour 0), and at post-dose Hours 3, 8, 12, 24, 48, 72, 360, and 1056. Of the 36 subjects enrolled into the study, 31 subjects completed the study in its entirety. Five (5) subjects were dropped out from the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	fluoxetine HCL 40 mg capsules

Timeline

• Start date: 2003-08-01
• Primary completion: 2003-10-01
• Completion: 2003-12-01
• First posted: 2008-10-23
• Last updated: 2009-12-15

Locations

1 site across 1 country: United States