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Sponsored by: |
Mylan Pharmaceuticals |
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Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00648193 |
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 fasting conditions to healthy adult volunteers.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Paroxetine hydrochloride 40 mg tablet Drug: Paxil® 40 mg Table |
Phase 0 |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Single-Dose Fasting Bioequivalence Study of Paroxetine Hydrochloride Tablets (40 mg; Mylan) and Paxil® Tablets (40 mg; GSK) in Healthy Adult Volunteers |
Enrollment: | 36 |
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
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Drug: Paroxetine hydrochloride 40 mg tablet
40mg, single dose fasting
|
2: Active Comparator
Paxil® 40 mg Table
|
Drug: Paxil® 40 mg Table
40mg, single dose fasting
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and/or female of non-childbearing potential.
Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
United States, Missouri | |
Gateway Medical Research, Inc. | |
St. Charles, Missouri, United States, 63301 |
Principal Investigator: | Bruce T Czarnik, M.D. | Cetero Research |
Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | PARO-0678 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00648193 |
Health Authority: | United States: Institutional Review Board |
Healthy Paroxetine 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 |