Status:
COMPLETED
PAXIL CR Bioequivalence Study
Lead Sponsor:
GlaxoSmithKline
Conditions:
Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 7 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2008
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT00749359
Start Date
July 7 2008
End Date
September 16 2008
Last Update
August 4 2017
Active Locations (2)
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1
GSK Investigational Site
Buffalo, New York, United States, 14202
2
GSK Investigational Site
Tacoma, Washington, United States, 98418