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

A Comparative Bioavailability Study of Fluoxetine Hydrochloride Capsules, 40 mg

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00947076

Enrollment

Registered

2009-07-27

Start date

2001-02-28

Completion date

2001-04-30

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

Keywords

Antidepressant

Brief summary

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

Interventions

DRUGFluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)

DRUGFluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 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	42 days

Outcome results

None listed

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