PAXIL CR Bioequivalence Study

• Status: Completed
• Trial end date: 2008-09-16
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Paroxetine

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.