Official Title: “A Steady-State Study to Assess the Pharmacokinetic Profile of Paroxetine After 14 Day Repeated Daily Dosing of the Controlled Release Paroxetine Tablet (25 mg) in Healthy Chinese Subjects”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Study Primary Completion Date: June 2006

Intervention(s) in this Clinical Trial

• Drug: Paroxetine Controlled Release Tablet 25mg

Primary Measures

• pharmacokinetic parameters

Secondary Measures

• safety parameters(adverse events, lab test results,vital signs,electrocardiograph)

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00406432

Study ID Number: PCR104075

ClinicalTrials.gov Identifier: NCT00406432

Health Authority: China: State Food and Drug Administration