To Demonstrate the Relative Bioavailability of Fluoxetine Hydrochloride Capsules, 40 mg

Phase 1

Completed

• Conditions: Depression
• Interventions: Drug: Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly); Drug: Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)

• Registration Number: NCT00947076
• Lead Sponsor: Sandoz

Brief Summary

To demonstrate the relative bioavailability of fluoxetine hydrochloride capsules, 40 mg.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Primary Completion: 2001-04
• Study Completion: 2001-04
• Status Verified: 2009-07
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria

• Positive test results for HIV or hepatitis B or C.
• Treatment for drug or alcohol dependence.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)	Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)
1	Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)	Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	42 days