A Cross-over Study to Evaluate the Effect of WELLBUTRIN XL on Intraocular Pressure in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Intraocular pressure at Day -1, Days 1 & 14.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females.
- •Non-smokers
- •Agree to remain in the clinic for the time defined in the protocol.
- •Normal ECG.
排除标准
- •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.
研究组 & 干预措施
Treatment Group 1
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.
干预措施: WellbutrinXL (Drug)
Treatment Group 1
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.
干预措施: placebo (Drug)
Treatment Group 2
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.
干预措施: WellbutrinXL (Drug)
Treatment Group 2
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.
干预措施: placebo (Drug)
结局指标
主要结局
Intraocular pressure at Day -1, Days 1 & 14.
时间窗: at Day -1, Days 1 & 14.
次要结局
- 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)
- Intraocular pressure,Pupil diameter, anterior chamber angle(Days-1,1&14)
- Wellbutrin XL plasma level(Days1,12-14)