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Bioequivalence Study of Fluoxetine HCL 40 mg Capsules Under Fasting Conditions

2014-08-27 03:26:45 | BioPortfolio

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

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy

Intervention

fluoxetine HCL 40 mg capsules

Location

Gateway medical research
St. Charles
Missouri
United States
63301

Status

Completed

Source

Ranbaxy Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:26:45-0400

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