PAXIL CR Bioequivalence Study - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00749359

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	Drug: Paxil	Phase I

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Paroxetine blood levels measured up to 168 hours after a single dose.

Secondary Outcome Measures:

Additional pharmacokinetic parameters related to blood levels of paroxetine measured up to 168 hours after a single dose. Safety & tolerability measures including ae reporting throughout study & vitals signs & ECGs taken before dosing & at follow-up.

Estimated Enrollment:	166
Study Start Date:	July 2008

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749359

Locations

United States, New York
GSK Clinical Trials Call Center	Recruiting
Buffalo, New York, United States, 14202
Contact: Robert Blum 877-379-3718 rblum@bcrc.us
United States, Washington
GSK Clinical Trials Call Center	Recruiting
Tacoma, Washington, United States, 98418
Contact: Royce Morrison 877-379-3718 royce.morrison@crl.com

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

Medical monitor

More Information

Study ID Numbers:	PCR111656
Study First Received:	September 5, 2008
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00749359
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

healthy volunteers
paroxetine

Study placed in the following topic categories:

Healthy
Paroxetine

ClinicalTrials.gov processed this record on January 14, 2009