An Open-label, Single Dose, Randomized, Three-way Cross-over Study to Evaluate the Effect of Food on the Pharmacokinetics of Solifenacin and Tamsulosin Administered as Combination Tablet EC905 in Young, Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameter of solifenacin by Area Under the Curve from the time of dosing until the last measurable concentration (AUClast) in plasma
研究概览
简要总结
To evaluate the effect of food (low and high fat breakfast vs. fasting) on the pharmacokinetics (what the body does to the drug) of a single dose of solifenacin and tamsulosin administered as combination tablet EC905. Also to evaluate the safety and tolerability of single doses of EC905 in young, healthy male subjects, when administered under fed (low and high fat) or fasting conditions.
详细描述
Subjects are admitted to the clinic on Day -1 and receive a single dose of the combination tablet EC905 on the first day of 3 periods, under three conditions (high fat breakfast, low fat breakfast, and fasting) in order to evaluate the effect of food.
Blood sampling for pharmacokinetic (PK) assessment is performed on the dosing day and for 11 days after dosing in each period. This 11-day on-site period is repeated three times so that all subjects are dosed under all conditions. Each period is separated by 7 days off site.
Subjects return for an End of Study Visit (ESV) at least 7 days after the last 11 day on-site period, or after withdrawal.
On Day 1 of each of 3 periods, subjects are given a single dose of EC905 under three conditions (high fat breakfast, low fat breakfast and fasting) in order to evaluate the effect of food on the PK of solifenacin and tamsulosin HCl. The aim is to show the absence of a food effect after a low fat breakfast vs. fasting conditions, and to evaluate the food effect after a high fat breakfast vs. fasting conditions.
Subjects are randomized to one of 6 possible sequences of fasted or fed conditions.
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
- 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
- •BMI between 18.5 and 30.0 kg/m2, inclusive.
排除标准
- •Known or suspected hypersensitivity to solifenacin, tamsulosin or any of the other recipients of EC
- •Any of the contraindications or precautions for use as mentioned in the applicable sections of the Summary of Product Characteristics (SPC) of tamsulosin or solifenacin
- •Use of grapefruit (more than 3 x 200 ml) or marmalade (more than three times) in the week prior to admission to the Clinical Unit, as reported by the subject.
研究组 & 干预措施
1: fasted
EC905 + fasted
干预措施: EC905 (Drug)
2: low-fat breakfast
EC905 + low-fat breakfast
干预措施: EC905 (Drug)
3: high-fat breakfast
EC905 + high-fat breakfast
干预措施: EC905 (Drug)
结局指标
主要结局
Pharmacokinetic parameter of solifenacin by Area Under the Curve from the time of dosing until the last measurable concentration (AUClast) in plasma
时间窗: Days 1-11, 18-28, 35-45
area under the plasma concentration - time curve (AUC) from the time of dosing until the last measurable concentration (AUClast)
Pharmacokinetic parameter of tamsulosin HCl by maximum concentration (Cmax) in plasma
时间窗: Days 1-11, 18-28, 35-45
maximum concentration (Cmax)
Pharmacokinetic parameter of solifenacin by maximum concentration (Cmax) in plasma
时间窗: Days 1-11, 18-28, 35-45
maximum concentration (Cmax)
Pharmacokinetic parameter of tamsulosin HCl by Area Under the Curve from the time of dosing until the last measurable concentration (AUClast) in plasma
时间窗: Days 1-11, 18-28, 35-45
area under the plasma concentration - time curve (AUC) from the time of dosing until the last measurable concentration (AUClast)
次要结局
- Safety and tolerability of single doses of EC905 (solifenacin/tamsulosin HCl) under fed or fasted conditions(Screening (Day-21 to -1) to ESV (at least 7 days after the last 11 day on-site period, or after withdrawal))
- Pharmacokinetics profile of solifenacin concentration: (AUCinf), (t1/2), (tmax), (CL/F) and (Vz/F)(Days 1-11, 18-28, 35-45)
- Pharmacokinetics profile of tamsulosin HCl concentration: (AUCinf), (t1/2), (tmax), (CL/F) and (Vz/F)(Days 1-11, 18-28, 35-45)