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

• Status: Completed
• Trial end date: 2006-04-26
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Paroxetine

Criteria

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