A Phase 1, Open-label, One-sequence Study to Assess the Effect of Verapamil on the Steady State Pharmacokinetics of Solifenacin and Tamsulosin Administered as a Combination Tablet EC905 in Healthy Male Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of tamsulosin OCAS in plasma: AUCtau
研究概览
简要总结
This study investigates the effect of the co-administration of verapamil on the steady-state pharmacokinetics (PK) of solifenacin succinate and tamsulosin given as a combination tablet, EC905.
详细描述
The effect of the co-administration of verapamil on the steady state PK of solifenacin succinate and tamsulosin HCl OCAS (Oral Controlled Absorption System) is evaluated in this study.
Verapamil has been chosen to represent the effect of moderate CYP3A4 inhibitors on the combined administration of solifenacin and tamsulosin given as combination tablet EC905.
Subjects are admitted to the clinic on Day -1. From Days 1-10, they receive one daily dose of EC905 to obtain steady state, followed by 20 days (Days 11-30) combined dosing of EC905 and verapamil.
On Day 10 a 24-hour PK profile is obtained for solifenacin/tamsulosin. After the last dosing on Day 30, a post-dose 24-hour PK profile for solifenacin/tamsulosin and verapamil is obtained.
Additionally, vital signs, safety ECG (Electrocardiogram) measurements, safety laboratory assessments, adverse events and concomitant medications are monitored throughout the investigational period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index between 18.5 and 30.0 kg/m2, inclusive
排除标准
- •Known or suspected hypersensitivity to EC905 or any of the components of the formulation used
- •Known or suspected hypersensitivity to verapamil or any of the components of the formulation used
- •Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit
研究组 & 干预措施
1: verapamil + EC905
干预措施: EC905 (Drug)
1: verapamil + EC905
干预措施: verapamil (Drug)
结局指标
主要结局
Pharmacokinetics of tamsulosin OCAS in plasma: AUCtau
时间窗: Predose, Days 1, and 7-10
AUCtau (area under the plasma concentration-time curve during the time interval between consecutive dosing)
Pharmacokinetics of solifenacin in plasma: AUCtau
时间窗: Predose, Days 1, and 7-10
AUCtau (area under the plasma concentration-time curve during the time interval between consecutive dosing)
Pharmacokinetics of tamsulosin OCAS in plasma: Cmax
时间窗: Predose, Days 1, and 7-10
Cmax (maximum concentration)
Pharmacokinetics of solifenacin in plasma: Cmax
时间窗: Predose, Days 1, and 7-10
Cmax (maximum concentration)
次要结局
- Pharmacokinetics of combined doses of tamsulosin OCAS and solifenacin in steady state, and verapamil(Predose, Days 27-30)
- Safety and tolerability of the interaction between combined doses of tamsulosin OCAS and solifenacin, and verapamil(Screening to ESV (10 days after the last dosing))