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
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