NCT00913588

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 depression

Timeline
Completed

Started May 1996

Shorter than P25 for phase_1 depression

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1996

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 1996

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 1996

Completed
12.8 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
Last Updated

March 28, 2017

Status Verified

June 1, 2009

Enrollment Period

3 months

First QC Date

June 2, 2009

Last Update Submit

March 27, 2017

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    141 days

Study Arms (3)

1

EXPERIMENTAL

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

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

2

EXPERIMENTAL

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

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

3

ACTIVE COMPARATOR

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

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

Interventions

Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.)DRUG
1
Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.)DRUG
2
Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista)DRUG
3

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

You may not qualify if:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Roderick Malone, M.D.

    Clinical Research Center (Cincinnati)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 4, 2009

Study Start

May 1, 1996

Primary Completion

August 1, 1996

Study Completion

August 1, 1996

Last Updated

March 28, 2017

Record last verified: 2009-06