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

GlaxoSmithKline6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depressive Disorder

Interventions

Paroxetine controlled release tabletDRUG

Paroxetine will be given as single dose, controlled release tablet with dosing strengths of 12.5, 25 and 37.5 milligrams in fasted state separated by a wash-out period of 10 days.

Eligibility

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

Medical Language ↔ Plain English

Inclusion criteria: * 19-45 years healthy Chinese * 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

To obtain pharmacokinetic parameters of paroxetine paroxetine CR tablet (12.5 to 37.5 mg) in healthy Chinese subjects

Time frame: Up to 32 days

Secondary Outcomes

To describe Safety profile of healthy subjects when dosed with paroxetine controlled release

Time frame: Up to 32 days

Data from ClinicalTrials.gov

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