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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00648427 |
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 fasting 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: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Single-Dose Fasting 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: | April 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Paroxetine Hydrochloride Controlled-Release Tablets 25 mg
|
Drug: Paroxetine Hydrochloride Controlled-Release Tablets 25 mg
25mg, single dose fasting
|
|
Active Comparator: 2
Paxil CR™ Tablets 25 mg
|
Drug: Paxil CR™ Tablets 25 mg
25mg, 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 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, M.D. | PRACS Institute Ltd. |
More Information
| Responsible Party: | Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc. |
| ClinicalTrials.gov Identifier: | NCT00648427 History of Changes |
| Other Study ID Numbers: | PARO-0509 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Paroxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents |
Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |