NCT02108288已完成1 期
Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Cmax of Carteolol
研究概览
简要总结
OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating the combination drug will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects who are considered medically healthy per investigator's judgment
排除标准
- •Subjects with ocular conditions as defined by the protocol
- •Subjects with intraocular pressure: <10 or ≥22 mmHg
研究组 & 干预措施
OPC-1085EL ophthalmic solution
Experimental
Once daily
干预措施: OPC-1085EL ophthalmic solution (Drug)
Carteolol long-acting ophthalmic solution
Active Comparator
Once daily
干预措施: Carteolol long-acting ophthalmic solution (Drug)
Latanoprost ophthalmic solution
Active Comparator
Once daily
干预措施: Latanoprost ophthalmic solution (Drug)
结局指标
主要结局
Cmax of Carteolol
时间窗: Day 1 and Day 7
Cmax of Latanoprost Acid
时间窗: Day 1 and Day 7
次要结局
- Tmax of Carteolol(Day 1 and Day 7)
- Tmax of Latanoprost Acid(Day 1 and Day 7)
研究者
相似试验
未知
3 期
Comparative Study of OPC-1085EL Ophthalmic Solution to Carteolol Hydrochloride Long-Acting Ophthalmic Solution 2% in Subjects with Primary Open-Angle Glaucoma or Ocular Hypertension (Phase 3 study)Glaucoma or ocular hypertensionJPRN-jRCT2080222438Otsuka Pharmaceutical Co., Ltd.175
未知
3 期
Comparative Study of OPC-1085EL Ophthalmic Solution to Latanoprost Ophthalmic Solution 0.005% in Subjects with Primary Open-Angle Glaucoma or Ocular Hypertension (Phase 3 study)Glaucoma or ocular hypertensionJPRN-jRCT2080222437Otsuka Pharmaceutical Co., Ltd.220
已完成
3 期
Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular HypertensionGlaucomaOcular HypertensionNCT02105285Otsuka Pharmaceutical Co., Ltd.193
已完成
3 期
Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular HypertensionGlaucomaOcular HypertensionNCT02105272Otsuka Pharmaceutical Co., Ltd.237
已完成
1 期
Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 1.5% in 48 Healthy VolunteersEye Infections, BacterialNCT00357292Laboratoires Thea