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This study will be conducted in healthy volunteers to investigate the effect on intraocular pressure of 2 weeks of treatment with 300mg WELLBUTRIN XL/day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Experimental | Subjects in Period 1 of treatment group 1 will receive oral doses of extended release WELLBUTRIN XL tablets for 2 weeks, from Days 1-3 subject will receive 150 milligram (mg) tablets once daily (QD) and from Days 4-14 300 mg QD. In Period 2 subject will receive placebo for 2 weeks. |
|
| Treatment Group 2 | Experimental | Subjects in Period 1 of Treatment group 2 will receive Placebo for 2 weeks and in Period 2 subject will receive oral doses of extended release WELLBUTRIN XL for 2 weeks, from Days 1-3 subject will receive 150 milligram (mg) tablets once daily (QD) and from Days 4-14 300 mg QD. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WellbutrinXL | Drug | WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg. |
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| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure at Day -1, Days 1 & 14. | at Day -1, Days 1 & 14. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure,Pupil diameter, anterior chamber angle | Days-1,1&14 | |
| Wellbutrin XL plasma level | Days1,12-14 | |
| adverse events |
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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 | Gainesville | Florida | 32605 | United States |
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| Label | URL |
|---|---|
| Results for study WXL108709 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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| placebo | Drug | Matching placebo tablets to WELLBUTRIN XL. |
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| each visit |
| lab tests,ECG,vital signs: | screening,followup |
| lab tests: | Days-2,13-14 |
| ECG: | Day 14 |
| vital signs: | Days-2,-1,1,14 |