A Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects

• Status: Completed
• Trial end date: 2006-06-02
• Target enrollment: 0
• Participant gender: All

Summary

The study was designed to assess the steady-state pharmacokinetic profile of paroxetine after 14 day repeated daily dosing of the controlled release tablet formulation (25 mg) in healthy Chinese subjects.

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Paroxetine

Criteria

Inclusion criteria:

• 19-45 years healthy Chinese subjects

• Body weight > 50 kg

• BMI between 19-25

• serological negative for HIV, syphilis and hepatitis B and C

• no abnormalities in ECG

• Female with negative pregnancy and male has no plan to have a child during and 3 months after the study.

Exclusion criteria:

• History of chronic physical/mental disease, current disease and concomitant medication