Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) 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

NCT00406003

PCR104074

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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6 participants in 6 patient groups

Subjects receiving treatment sequence ABC

Experimental group

Description:

Eligible subjects will receive treatment sequence ABC; A= paroxetine 12.5 milligrams, B= paroxetine 25 milligrams, and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days.

Treatment:

Drug: Paroxetine controlled release tablet

Subjects receiving treatment sequence BAC

Experimental group

Description:

Eligible subjects will receive treatment sequence BAC; B= paroxetine 25 milligrams, A= paroxetine 12.5 milligrams and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days.

Treatment:

Drug: Paroxetine controlled release tablet

Subjects receiving treatment sequence CBA

Experimental group

Description:

Eligible subjects will receive treatment sequence CBA; C= paroxetine 37.5 milligrams, B= paroxetine 25 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days.

Treatment:

Drug: Paroxetine controlled release tablet

Subjects receiving treatment sequence BCA

Experimental group

Description:

Eligible subjects will receive treatment sequence BCA; B= paroxetine 25 milligrams, C= paroxetine 37.5 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days.

Treatment:

Drug: Paroxetine controlled release tablet

Subjects receiving treatment sequence CAB

Experimental group

Description:

Eligible subjects will receive treatment sequence CAB; C= paroxetine 37.5 milligrams, A= paroxetine 12.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days.

Treatment:

Drug: Paroxetine controlled release tablet

Subjects receiving treatment sequence ACB

Experimental group

Description:

Eligible subjects will receive treatment sequence ACB; A= paroxetine 12.5 milligrams, C= paroxetine 37.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days.

Treatment:

Drug: Paroxetine controlled release tablet