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NCT00406432 Clinical Trial

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

Depressive Disorder Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00406432
Other study ID # PCR104075
Secondary ID
Status Completed
Phase Phase 1
First received November 30, 2006
Last updated September 27, 2017
Start date May 9, 2006
Est. completion date June 2, 2006

Study information
Verified date September 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date June 2, 2006
Est. primary completion date June 2, 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Paroxetine Controlled Release Tablet
Eligible subjects will receive paroxetine controlled release tablet with dose of 25 milligrams.

Locations
Country Name City State
China GSK Investigational Site Beijing

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary pharmacokinetic parameters Up to 21 days
Secondary safety parameters(adverse events, lab test results,vital signs,electrocardiograph) Up to 21 days
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