A Randomized, Open-label, 2-period, Parallel Group, Multiple-dose Study to Evaluate the Drug-drugs Interaction Between Dorzolamide and Brimonidine in Healthy Korean Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Plasma concentration of Brimonidine and Dorzolamide
研究概览
简要总结
To assess the pharmacokinetic Interaction between Dorzolamide and Brimonidine in healthy male subjects.
详细描述
Clinical trial to evaluate the influence of drug and drug-drug interactions of Brimonidine and Dorzolamide co-administration on the pharmacokinetics of Brimonidine and pharmacokinetics of Dorzolamide in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male adults aged between 19 and 50 during screening period
- •BMI more than 18kg / m2 and less than 30kg / m2 and weight more than 55kg
- •Signed the informed consent form prior to study participation.
排除标准
- •Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
研究组 & 干预措施
[A]→[A]+[B]
Period 1 : At each dosing of Treatment A eye drops is administered for 8days
Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 92days
干预措施: [A] (Drug)
[A]→[A]+[B]
Period 1 : At each dosing of Treatment A eye drops is administered for 8days
Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 92days
干预措施: [A]+[B](1) (Drug)
[B]→[A]+[B]
Period 1 : At each dosing of Treatment B eye drops is administered for 92days
Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 8days
干预措施: [B] (Drug)
[B]→[A]+[B]
Period 1 : At each dosing of Treatment B eye drops is administered for 92days
Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 8days
干预措施: [A]+[B](2) (Drug)
结局指标
主要结局
Plasma concentration of Brimonidine and Dorzolamide
时间窗: pre- and post dose of Brimonidine and Dorzolamide administration]
Group 1 Brimonidine Period 1 : 1d 0h,7d 0h,7d 12h,8d 0h(pre-dose), 8d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 15 Point) Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h, 100d 0h(pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 21Point) Dorzolamide Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h,100d 0h (pre-dose), 100d 0.25,0.5,0.75,1,1.5,2,2.5,3,4,8,12 h post-dose (Total 21Point) Group 2 Brimonidine Period 2 : 93d 0h,99d 0h,99d 12h,100d 0h(pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5,2,2.5,3,4,8,12h post-dose (Total 15Point) Dorzolamide Period 1 : 1d 0h, 15d 0h, 29d 0h, 43d 0h, 57d 0h, 71d 0h, 85d 0h, 91d 0h, 91d 12h, 92d 0h (pre-dose), 92d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 21Point) Period 2 : 93d 0h, 99d 0h, 99d 12h, 100d 0h (pre-dose), 100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 15Point)
次要结局
- Trough concentration of Dorzolamide and N-Desethyl-Dorzloamide(pre- and post dose of Dorzolamide and Dorzloamide administration])