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

Comparative, Randomized, Single-Dose, 3-way Crossover Bioavailability Study of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Health Adult Males Under Fed and Fasted Conditions Following Administration of a 40 mg Dose

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00913588

Enrollment

Registered

2009-06-04

Start date

1996-05-31

Completion date

1996-08-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Brief summary

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.

Interventions

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

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

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Bioequivalence based on AUC and Cmax	141 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026