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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00648193 |
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 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
|
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
|
Eligibility| 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:
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-0678 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00648193 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 Paroxetine Serotonin Uptake Inhibitors |
Pharmacologic Actions Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |