To Demonstrate the Relative Bioavailability of Fluoxetine Hydrochloride Capsules, 40 mg
March 27, 2017 updated by: Sandoz
A Comparative Bioavailability Study of Fluoxetine Hydrochloride Capsules, 40 mg
To demonstrate the relative bioavailability of fluoxetine hydrochloride capsules, 40 mg.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)
|
|
|
Active Comparator: 2
Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Bioequivalence based on AUC and Cmax
Time Frame: 42 days
|
42 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ronald Goldwater, M.D., PharmaKinetics Laboratories Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2001
Primary Completion (Actual)
April 1, 2001
Study Completion (Actual)
April 1, 2001
Study Registration Dates
First Submitted
July 24, 2009
First Submitted That Met QC Criteria
July 24, 2009
First Posted (Estimate)
July 27, 2009
Study Record Updates
Last Update Posted (Actual)
March 28, 2017
Last Update Submitted That Met QC Criteria
March 27, 2017
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Depression
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Fluoxetine
Other Study ID Numbers
- 005-49-11634
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.