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Sponsored by: |
Mylan Pharmaceuticals |
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Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00649636 |
The objective of this study is to investigate the bioequivalence of Mylan's fluoxetine hydrochloride 40 mg capsules to Dista's Prozac 40 mg pulvules following a single, oral 40 mg (1 x 40 mg) dose administration under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Fluoxetine Capsules 40 mg Drug: Prozac Pulvules 40 mg |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Single-Dose Fasting Bioequivalence Study of Fluoxetine Capsules (40 mg; Mylan) and Prozac Pulvules (40 mg; Dista) in Healthy Adult Volunteers |
Enrollment: | 32 |
Study Start Date: | February 2006 |
Study Completion Date: | April 2006 |
Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Fluoxetine Capsules 40 mg
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Drug: Fluoxetine Capsules 40 mg
40mg, single dose fasting
|
2: Active Comparator
Prozac Pulvules 40 mg
|
Drug: Prozac Pulvules 40 mg
40mg, single dose fasting
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, North Dakota | |
PRACS Institute, Ltd. | |
Fargo, North Dakota, United States, 58104 |
Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute Ltd. |
Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | FLUO-0603 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00649636 |
Health Authority: | United States: Institutional Review Board |
Fluoxetine Healthy Serotonin |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Antidepressive Agents, Second-Generation Central Nervous System Agents Serotonin Uptake Inhibitors Antidepressive Agents Pharmacologic Actions |