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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00406432

Enrollment

Registered

2006-12-04

Start date

2006-05-09

Completion date

2006-06-02

Last updated

2017-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder

Keywords

BRL029060/Paroxetine CR, pharmacokinetics, repeat dose

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.

Interventions

DRUGParoxetine Controlled Release Tablet

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
pharmacokinetic parameters	Up to 21 days

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026