Last updated: 11/04/2018 10:12:39
A Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A steady-state study to assess the pharmacokinetic profile of paroxetine after 14 day repeated daily dosing of the controlled release paroxetine tablet (25 mg) in healthy Chinese subjects
Trial description: 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 subjects.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
pharmacokinetic parameters
Timeframe: Up to 21 days
Secondary outcomes:
safety parameters(adverse events, lab test results,vital signs,electrocardiograph)
Timeframe: Up to 21 days
Interventions:
Drug: Paroxetine Controlled Release Tablet
Enrollment:
12
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Depressive Disorder
Product
paroxetine
Collaborators
Not applicable
Study date(s)
May 2006 to June 2006
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
19 - 45 years
Accepts healthy volunteers
Yes
- 19-45 years healthy Chinese subjects
- Body weight > 50 kg
- History of chronic physical/mental disease, current disease and concomitant medication
Inclusion and exclusion criteria
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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-02-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study PCR104075 can be found on the GSK Clinical Study Register.
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