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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Depressive Disorder

Treatments: Drug: Paroxetine Controlled Release Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00406432

PCR104075

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Subjects receiving paroxetine

Experimental group

Description:

Eligible subjects will receive single dose of paroxetine 25 milligrams controlled release formulation followed by wash-out period of 5 days. Subjects will receive multiple doses of paroxetine 25 milligrams for further 14 days.

Treatment:

Drug: Paroxetine Controlled Release Tablet