PAXIL CR Bioequivalence Study
PAXIL CR Bioequivalence Study
This study is to determine if controlled release paroxetine tablets manufactured at two
 different sites behave similarly in healthy volunteers.
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.