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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacokinetics; Depressive Disorder

Intervention: Paroxetine controlled Release 12.5mg, 25mg and37.5mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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

Clinical Details

Official title: A Randomized, Open, Three-period Crossover Study to Compare the Pharmacokinetic Profile of Paroxetine After Single Dosing of Each Enteric-coated Geomatrix Control Release Tablet Strength (12.5, 25, 37.5mg) in Healthy Chinese Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To obtain pharmacokinetic parameters of paroxetine paroxetine CR tablet (12.5 to 37.5 mg) in healthy Chinese subjects

Secondary outcome: To describe Safety profile of healthy subjects when dosed with paroxetine controlled release

Eligibility

Minimum age: 19 Years. Maximum age: 45 Years. Gender(s): Both.

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

Locations and Contacts

GSK Investigational Site, Beijing 100730, China
Additional Information

Starting date: March 2006
Last updated: May 31, 2012

Page last updated: August 23, 2015

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