The Effect of Paroxetine on the Plasma Levels of Timolol Using Ophthalmic 0.5% Timolol Eye Drops and 0.1% Timolol Eye Gel in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Santen Oy
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The primary parameters will be timolol area under the plasma drug concentration-time curve (AUC0-12h) and highest drug concentration observed in plasma (Cmax).
研究概览
简要总结
The aim of the study is to investigate the effect of antidepressant paroxetine, on the plasma levels of timolol and its main metabolites after topical application of ophthalmic timolol products.
This will be a phase I, randomised, 4-phase cross-over study in healthy volunteers. Healthy male volunteers aged 18 - 40 years will be enrolled.
Placebo or paroxetine will be given for three days after which 1 drop of timolol product will be administered once in both eyes.
The duration of the paroxetine or placebo treatment period will be 3 days. There will be four different treatment periods. A washout between the study periods will be at least 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18 - 40 years of age
- •be in good general health
- •be willing to follow instructions
- •provide a written informed consent
- •have a BMI of 18.5 - 26
- •have systolic blood pressure at least 105 mmHg
- •have haemoglobin at least 135 g/l.
排除标准
- •known hypersensitivity to timolol, paroxetine or any component of the study medications
- •any contraindications to timolol treatment including asthma and obstructive lung disease
- •any contraindications to paroxetine treatment
- •have heart rate 50/min or less in rest
- •any regular medication
- •allergy requiring antihistamine or ocular or nasal treatment
- •clinically significant abnormalities (from normal limits) in laboratory values: basic blood count, creatinine, ALAT, AFOS, gamma-GT, K, Na
- •clinically significant EKG abnormalities assessed by the investigator
- •blood donation within the last 60 days (the required time period between two donations for men given by RedCross Finland).
- •participation in another clinical trial involving an investigational drug/device, or participation in such trial within the last 60 days
研究组 & 干预措施
Paroxetine
干预措施: Paroxetine (Drug)
Gelatine capsule
干预措施: Placebo (Drug)
Timolol 0.5 % eye drops
The plasm levels of timolol will be measured after one drop of timolol has been administered into both eyes.
干预措施: timolol maleate (Drug)
Timosan 0.1% eye gel
The plasm levels of timolol will be measured after one drop of timolol has been administered into both eyes.
干预措施: timolol maleate (Drug)
结局指标
主要结局
The primary parameters will be timolol area under the plasma drug concentration-time curve (AUC0-12h) and highest drug concentration observed in plasma (Cmax).
时间窗: 1 day
次要结局
未报告次要终点