Status:
COMPLETED
Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) 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 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) ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 24 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2006
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00406003
Start Date
March 24 2006
End Date
April 26 2006
Last Update
September 29 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Beijing, China, 100730