To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fasting Conditions

Sandoz46 enrolled

Overview

To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fasting conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression

Interventions

Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.)DRUG

Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)DRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 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: 86 days

Data from ClinicalTrials.gov

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