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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649636 |
Purpose
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
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, North Dakota | |
| PRACS Institute, Ltd. | |
| Fargo, North Dakota, United States, 58104 | |
| Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute Ltd. |
More Information
| 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 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors Pharmacologic Actions |
Fluoxetine Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |