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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving paroxetine | Experimental | Eligible subjects will receive single dose of paroxetine 25 milligrams controlled release formulation followed by wash-out period of 5 days. Subjects will receive multiple doses of paroxetine 25 milligrams for further 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paroxetine Controlled Release Tablet | Drug | Eligible subjects will receive paroxetine controlled release tablet with dose of 25 milligrams. |
|
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetic parameters | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| safety parameters(adverse events, lab test results,vital signs,electrocardiograph) | Up to 21 days |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Beijing | 100730 | China |
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| Label | URL |
|---|---|
| Results for study PCR104075 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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