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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00647881 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan's paroxetine hydrochloride controlled-release 25 mg tablets to GSK's Paxil CR™ 25 mg tablets following a single, oral 25 mg (1 x 25 mg) dose administered under fed conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Paroxetine Hydrochloride Controlled-Release Tablets 25 mg Drug: Paxil CR™ Tablets 25 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Single-Dose Food In Vivo Bioequivalence Study of Paroxetine Hydrochloride Controlled-Release Tablets (25 mg; Mylan) to Paxil CR™ Tablets (25 mg; GlaxoSmithKline) in Healthy Volunteers |
| Enrollment: | 75 |
| Study Start Date: | April 2005 |
| Study Completion Date: | May 2005 |
| Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Paroxetine Hydrochloride Controlled-Release Tablets 25 mg
|
Drug: Paroxetine Hydrochloride Controlled-Release Tablets 25 mg
25mg, single dose fed
|
|
2: Active Comparator
Paxil CR™ Tablets 25 mg
|
Drug: Paxil CR™ Tablets 25 mg
25mg, single dose fed
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and/or non-pregnant, non-lactating female.
Women must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapies are permitted in this study. Acceptable forms of contraception include the following:
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, 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: | PARO-0510 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00647881 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 |