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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Drug: Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.); Drug: Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913718

960380

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

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

2

Active Comparator group

Description:

Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)

Treatment:

Drug: Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)