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
NCT00913588 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2017-03-28
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.
Conditions
Interventions
- DRUG
-
Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.)
- DRUG
-
Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.)
- DRUG
-
Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Roderick Malone, M.D. · Clinical Research Center (Cincinnati)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 1996-05-31
- Primary Completion
- 1996-08-31
- Completion
- 1996-08-31
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