Status:
COMPLETED
A Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Depressive Disorder
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief Summary
The study was designed to assess the steady-state pharmacokinetic profile of paroxetine after 14 day repeated daily dosing of the controlled release tablet formulation (25 mg) in healthy Chinese subje...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 19-45 years healthy Chinese subjects
- 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
Exclusion
Key Trial Info
Start Date :
May 9 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00406432
Start Date
May 9 2006
End Date
June 2 2006
Last Update
September 29 2017
Active Locations (1)
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1
GSK Investigational Site
Beijing, China, 100730