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

GlaxoSmithKline12 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depressive Disorder

Interventions

Paroxetine Controlled Release TabletDRUG

Eligible subjects will receive paroxetine controlled release tablet with dose of 25 milligrams.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Beijing, China

Outcomes

Primary Outcomes

pharmacokinetic parameters

Time frame: Up to 21 days

Secondary Outcomes

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

Time frame: Up to 21 days

Data from ClinicalTrials.gov

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