Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects

Phase 1

Completed

• Conditions: Depressive Disorder
• Interventions: Drug: Paroxetine controlled release tablet

• Registration Number: NCT00406003
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The study was designed to describe the relationship between dose and pharmacokinetic parameters of paroxetine over the range of proposed dosage strengths of the paroxetine CR tablet (12.5 to 37.5 mg) as well as safety profile

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-24
• Primary Completion: 2006-04-26
• Study Completion: 2006-04-26
• 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: 6

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Subjects receiving treatment sequence BCA	Paroxetine controlled release tablet	Eligible subjects will receive treatment sequence BCA; B= paroxetine 25 milligrams, C= paroxetine 37.5 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days.
Subjects receiving treatment sequence CAB	Paroxetine controlled release tablet	Eligible subjects will receive treatment sequence CAB; C= paroxetine 37.5 milligrams, A= paroxetine 12.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days.
Subjects receiving treatment sequence BAC	Paroxetine controlled release tablet	Eligible subjects will receive treatment sequence BAC; B= paroxetine 25 milligrams, A= paroxetine 12.5 milligrams and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days.
Subjects receiving treatment sequence ABC	Paroxetine controlled release tablet	Eligible subjects will receive treatment sequence ABC; A= paroxetine 12.5 milligrams, B= paroxetine 25 milligrams, and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days.
Subjects receiving treatment sequence ACB	Paroxetine controlled release tablet	Eligible subjects will receive treatment sequence ACB; A= paroxetine 12.5 milligrams, C= paroxetine 37.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days.
Subjects receiving treatment sequence CBA	Paroxetine controlled release tablet	Eligible subjects will receive treatment sequence CBA; C= paroxetine 37.5 milligrams, B= paroxetine 25 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days.

Primary Outcome Measures

Name	Time	Method
To obtain pharmacokinetic parameters of paroxetine paroxetine CR tablet (12.5 to 37.5 mg) in healthy Chinese subjects	Up to 32 days

Secondary Outcome Measures

Name	Time	Method
To describe Safety profile of healthy subjects when dosed with paroxetine controlled release	Up to 32 days

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇳 Beijing, China