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| Sponsored by: |
Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00650403 |
Purpose
The objective of this study is to investigate the bioequivalence of Mylan's paroxetine hydrochloride 40 mg tablets to GSK's Paxil® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fed conditions to healthy adult volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Paroxetine hydrochloride 40 mg tablet Drug: Paxil® 40 mg Tablet |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Single-Dose Fed Bioequivalence Study of Paroxetine Hydrochloride Tablets (40 mg; Mylan) and Paxil® Tablets (40 mg; GSK) in Healthy Adult Volunteers |
| Enrollment: | 66 |
| Study Start Date: | December 2006 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Paroxetine hydrochloride 40 mg tablet
|
Drug: Paroxetine hydrochloride 40 mg tablet
40mg, single dose fed
|
|
2: Active Comparator
Paxil® 40 mg Tablet
|
Drug: Paxil® 40 mg Tablet
40mg, single dose fed
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Medications: a. Use of any prescription or over-the-counter (OTC) medication within the 14 days prior to the initial dose of study medication. b.
Use of any hormonal contraceptives or hormone replacement therapy within 3 months prior to study medication dosing. c. Use of any medication within 28 days prior to initial dose of study medication unless the Pharmacokinetics/Drug Metabolism Department at Mylan was consulted and a decision was made to allow the subjects to enroll based on the medications pharmacology and pharmacokinetics. d. Use of monoamine oxidase inhibitors (MAOIs), pimozide, or thioridazine within 30 days prior to the initial dosing of study medication.
Contacts and Locations| United States, Missouri | |
| Gateway Medical Research, Inc. | |
| St. Charles, Missouri, United States, 63301 | |
| Principal Investigator: | Bruce T Czarnik, M.D. | Cetero Research |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | PARO-0679 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00650403 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Neurotransmitter Agents Psychotropic Drugs Healthy Antidepressive Agents, Second-Generation |
Serotonin Uptake Inhibitors Paroxetine Antidepressive Agents Serotonin |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Paroxetine Serotonin Uptake Inhibitors |
Pharmacologic Actions Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |