A Phase I, Randomized, Double-masked, 3-period Cross-over Clinical Study to Compare the Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops to Those of Preservative-free Tafluprost 0.0015% and Timolol 0.5% Eye Drops 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
- 15
- 试验地点
- 1
- 主要终点
- Pharmacokinetics after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.
研究概览
简要总结
The objective of this study is to investigate the pharmacokinetics, safety and tolerability of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (FDC) to those of preservative-free tafluprost 0.0015% and timolol 0.5% eye drops in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 45 years
- •Good general health
- •Meet best corrected ETDRS visual acuity
排除标准
- •Significant systemic or ocular disease
- •History of eye surgery, including refractive surgery
- •Allergy or hypersensitivity to study drug
- •Low heart rate (<50 bpm)
- •Clinically relevant low blood pressure
- •Bradycardia
- •Use of contact lenses within one week prior to screening or during the study
- •Clinically significant obesity (body mass index > 30 kg/m2)
- •Blood donation within 2 months prior to screening
- •Females who are pregnant or lactating and females not using adequate contraceptives
研究组 & 干预措施
Tafluprost 0.0015%
干预措施: Preservative free tafluprost 0.0015% eye drops (Drug)
Timolol 0.5%
干预措施: Preservative free timolol 0.5% eye drops (Drug)
Fixed-dose combination of tafluprost 0.0015% and timolol 0.5%
干预措施: Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops (Drug)
结局指标
主要结局
Pharmacokinetics after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.
时间窗: There are 3 cross-over treatment periods, plasma concentrations will be measured on Day 1 and Day 7
The primary evaluation of pharmacokinetics will be based on the plasma concentration of tafluprost acid and timolol.
次要结局
- Safety and tolerability after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.(Day 1 and Day 7 of treatment periods I, II and III.)