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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Drug: Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.); Drug: Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.); Drug: Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913588

960379

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 fed and fasted conditions.

Enrollment: 24 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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24 participants in 3 patient groups

1

Experimental group

Description:

Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.)

Treatment:

Drug: Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.)

2

Experimental group

Description:

Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.)

Treatment:

Drug: Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.)

3

Active Comparator group

Description:

Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista)

Treatment:

Drug: Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista)