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This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open label treatment | Experimental | On each treatment period, subjects will receive controlled release paroxetine 37.5 milligram (mg) on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paxil CR | Drug | Paxil CR 37mg tablet manufactures at two different sites |
|
| Measure | Description | Time Frame |
|---|---|---|
| Paroxetine blood levels | measured up to 168 hours after a single dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Additional pharmacokinetic parameters related to blood levels of paroxetine . Safety & tolerability measures including ae reporting & vitals signs & ECGs | measured up to 168 hours after a single dose and throughout study |
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Key Inclusion:
Healthy males or females between 18-65. Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-30 kg/m2. Willing to use acceptable forms of birth control throughout the study. Normal labs and ECG.
Key Exclusion:
Positive test for drugs or alcohol. Positive for Hepatitis or HIV. Any history of psychiatric disorder or suicidal behavior. Has taken another investigational product within 30 days of the start of this study. Has been exposed to more than 4 new chemical entities in the last 12 months. Females who are pregnant or nursing. Regular consumption of alcohol; >14 drinks/week for men or >7 drinks/week for women. Heavy smokers; greater than 20 cigarettes per day.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Buffalo | New York | 14202 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| Results for study PCR111656 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| PCR111656 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Tacoma |
| Washington |
| 98418 |
| United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| PCR111656 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| PCR111656 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| PCR111656 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| PCR111656 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| PCR111656 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| PCR111656 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |