To Demonstrate the Relative Bioavailability of Fluoxetine Hydrochloride Capsules, 40 mg
Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc) (Drug); Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Sandoz Inc. Official(s) and/or principal investigator(s): Ronald Goldwater, M.D., Principal Investigator, Affiliation: PharmaKinetics Laboratories, Inc.
Summary
To demonstrate the relative bioavailability of fluoxetine hydrochloride capsules, 40 mg.
Clinical Details
Official title: A Comparative Bioavailability Study of Fluoxetine Hydrochloride Capsules, 40 mg
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence based on AUC and Cmax
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: February 2001
Last updated: July 24, 2009
|