NCT00947076

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 depression

Timeline
Completed

Started Feb 2001

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

February 1, 2001

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
Last Updated

March 28, 2017

Status Verified

July 1, 2009

Enrollment Period

2 months

First QC Date

July 24, 2009

Last Update Submit

March 27, 2017

Conditions

Depression

Keywords

Antidepressant

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    42 days

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)

2

ACTIVE COMPARATOR

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

Drug: Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)

Interventions

Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)DRUG
1
Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)DRUG
2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
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

  • Ronald Goldwater, M.D.

    PharmaKinetics Laboratories Inc.

    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

July 24, 2009

First Posted

July 27, 2009

Study Start

February 1, 2001

Primary Completion

April 1, 2001

Study Completion

April 1, 2001

Last Updated

March 28, 2017

Record last verified: 2009-07