PAXIL CR Bioequivalence Study
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Purpose
This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Two Single Doses of Controlled Release Paroxetine Given 14 Days Apart Depressive Disorder Healthy Volunteer |
Drug: Paxil CR |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | An Open-label, Randomized, Single Dose, Two-period Crossover Study to Demonstrate Bioequivalence Between the Controlled Release Paroxetine Tablet (37.5 mg) Manufactured at Cidra and Mississauga |
- Paroxetine blood levels [ Time Frame: measured up to 168 hours after a single dose. ] [ Designated as safety issue: No ]
- Additional pharmacokinetic parameters related to blood levels of paroxetine . Safety & tolerability measures including ae reporting & vitals signs & ECGs [ Time Frame: measured up to 168 hours after a single dose and throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 166 |
| Study Start Date: | July 2008 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: open label treatment |
Drug: Paxil CR
Paxil CR 37mg tablet manufactures at two different sites
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Key Inclusion:
Healthy males or females between 18-65. Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-30 kg/m2. Willing to use acceptable forms of birth control throughout the study. Normal labs and ECG.
Key Exclusion:
Positive test for drugs or alcohol. Positive for Hepatitis or HIV. Any history of psychiatric disorder or suicidal behavior. Has taken another investigational product within 30 days of the start of this study. Has been exposed to more than 4 new chemical entities in the last 12 months. Females who are pregnant or nursing. Regular consumption of alcohol; >14 drinks/week for men or >7 drinks/week for women. Heavy smokers; greater than 20 cigarettes per day.
Contacts and Locations| United States, New York | |
| GSK Investigational Site | |
| Buffalo, New York, United States, 14202 | |
| United States, Washington | |
| GSK Investigational Site | |
| Tacoma, Washington, United States, 98418 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00749359 History of Changes |
| Other Study ID Numbers: | PCR111656 |
| Study First Received: | September 5, 2008 |
| Last Updated: | October 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
healthy volunteers paroxetine |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Mood Disorders Mental Disorders Behavioral Symptoms 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 |
ClinicalTrials.gov processed this record on June 17, 2013