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

Phase 1CompletedNCT00947076

Sandoz30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression

Interventions

Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)DRUG

Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Bioequivalence based on AUC and Cmax

Time frame: 42 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.