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

Phase 1

Completed

• Conditions: Depressive Disorder
• Interventions: Drug: Paroxetine Controlled Release Tablet

• Registration Number: NCT00406432
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-09
• Primary Completion: 2006-06-02
• Study Completion: 2006-06-02
• Study First Submitted: 2006-11-30
• Study First Submitted QC: 2006-11-30
• Study First Posted: 2006-12-04
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects receiving paroxetine	Paroxetine Controlled Release Tablet	Eligible subjects will receive single dose of paroxetine 25 milligrams controlled release formulation followed by wash-out period of 5 days. Subjects will receive multiple doses of paroxetine 25 milligrams for further 14 days.

Primary Outcome Measures

Name	Time	Method
pharmacokinetic parameters	Up to 21 days

Secondary Outcome Measures

Name	Time	Method
safety parameters(adverse events, lab test results,vital signs,electrocardiograph)	Up to 21 days

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇳 Beijing, China