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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

Page last updated: August 23, 2015

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