| February 22, 2007 |
| May 15, 2009 |
| February 2007 |
| |
| Intraocular pressure at Day -1, Days 1 & 14. [ Time Frame: at Day -1, Days 1 & 14. ] |
| Intraocular pressure at Day -1, Days 1 & 14. |
| Complete list of historical versions of study NCT00439868 on ClinicalTrials.gov Archive Site |
- Intraocular pressure,Pupil diameter, anterior chamber angle [ Time Frame: Days-1,1&14 ]
- Wellbutrin XL plasma level [ Time Frame: Days1,12-14 ]
- adverse events [ Time Frame: each visit ]
- lab tests,ECG,vital signs: [ Time Frame: screening,followup ]
- lab tests: [ Time Frame: Days-2,13-14 ]
- ECG: [ Time Frame: Day 14 ]
- vital signs: [ Time Frame: Days-2,-1,1,14 ]
|
| Intraocular pressure,Pupil diameter, anterior chamber angle:Days-1,1&14
Wellbutrin XL plasma level:Days1,12-14
adverse events: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 |
| |
| A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure |
| A Cross-Over Study to Evaluate the Effect of WELLBUTRIN XL on Intraocular Pressure in Healthy Volunteers |
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. |
| |
| Phase I |
| Interventional |
| Diagnostic, Non-Randomized, Double-Blind, Crossover Assignment, Pharmacodynamics Study |
| Healthy Subjects |
- Drug: WellbutrinXL
- Drug: placebo
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| |
| |
| |
| Completed |
| 33 |
|
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Inclusion Criteria:
- Healthy males or females.
- Non-smokers
- Agree to remain in the clinic for the time defined in the protocol.
- Normal ECG.
Exclusion Criteria:
- Any serious medical disorder or condition.
- Any history of an endocrine disorder.
- Any clinically significant laboratory abnormality.
- History of psychiatric illness.
- Any history of suicidal attempts or behavior.
- Risk factors for precipitation of angle closure glaucoma or elevated IOP.
- Inability to refrain from use of contact lenses during the study days, if correction is required.
- Self-administered Beck Depression Inventory II scale total score greater than 9, and a suicide question score of greater than zero.
- Current or past history of seizure disorder or brain injury (traumatic or disease-related); or any condition which, in the opinion of the investigator, predisposes to seizure - Women having a positive serum HCG pregnancy test at screening, a positive urine pregnancy test before admission to the Unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.
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| Both |
| 18 Years to 55 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00439868 |
| Study Director, GSK |
| WXL108709 |
| GlaxoSmithKline |
|
| Study Director: |
GSK Clinical Trials, MD |
GlaxoSmithKline |
|
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| GlaxoSmithKline |
| May 2009 |