Last updated: 11/04/2018 10:12:31
Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) 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 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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
To obtain pharmacokinetic parameters of paroxetine paroxetine CR tablet (12.5 to 37.5 mg) in healthy Chinese subjects
Timeframe: Up to 32 days
Secondary outcomes:
To describe Safety profile of healthy subjects when dosed with paroxetine controlled release
Timeframe: Up to 32 days
Interventions:
Drug: Paroxetine controlled release tablet
Enrollment:
6
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)
March 2006 to April 2006
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
19 - 45 years
Accepts healthy volunteers
Yes
- 19-45 years healthy Chinese
- 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
- 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
2006-26-04
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 PCR104074 can be found on the GSK Clinical Study Register.
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