Bioequivalence Study of Fluoxetine HCL 40 mg Capsules Under Fasting Conditions

ClinicalTrials.gov ID: NCT00778024

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Official title

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT00778024
Recruitment status: Completed
Study type: Interventional
Phase: Not applicable
Lead sponsor: Ranbaxy Laboratories Limited; Industry
Enrollment: 36 participants

Conditions and interventions

Conditions

Healthy

Interventions

fluoxetine HCL 40 mg capsules Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 2003 (Type not available)
Primary completion: Oct 2003 (Actual)
Completion: Dec 2003 (Actual)
Last update posted: Dec 15, 2009

2003

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Gateway medical research	Saint Charles	Missouri	63301	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00778024, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 15, 2009 · Synced Nov 13, 2026