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...
Date First Received: November 30, 2006
Last Updated: April 16, 2008
Verified by: GlaxoSmithKline, April 2008
Clinical Trial Phase: Phase 1 | Start Date: March 2006
Overall Status: Completed
Estimated Enrollment: 12
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study
Study Primary Completion Date: April 2006
Intervention(s) in this Clinical Trial
- Drug: Paroxetine controlled Release 12.5mg, 25mg and37.5mg
Outcome Measures for this Clinical Trial
Primary Measures
- To obtain pharmacokinetic parameters of paroxetine paroxetine CR tablet (12.5 to 37.5 mg) in healthy Chinese subjects
Secondary Measures
- To describe Safety profile of healthy subjects when dosed with paroxetine controlled release
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 19 Years
Maximum Age for this Clinical Trial: 45 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00406003
Study ID Number: PCR104074
ClinicalTrials.gov Identifier: NCT00406003
Health Authority: China: State Food and Drug Administration
Clinical Trials Authorship and Review
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