An Open-label, Parallel Group, Randomized, Two-sequence, Three-way Crossover Study to Assess the Relative Bioavailability of Solifenacin Succinate and Mirabegron Fixed-dose Combination Tablets Compared to Co-administration of Single Entity Tablets at Three Dose Strengths in Healthy Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameter of solifenacin in plasma as measured by AUCinf (AUC extrapolated until infinity)
研究概览
简要总结
This study compares the pharmacokinetics (PK), safety and tolerability of fixed dose combination (FDC) tablets containing solifenacin succinate and mirabegron with the co-administration of single entity tablets (SET), at three dose strengths.
详细描述
There are three parallel groups each with 24 healthy male and female subjects (with a minimum of 10 subjects per gender). Each group receives one dose strength.
The study utilizes a partial replicate cross-over design with three periods and each subject receives the same strength of either the FDC or SET formulation twice.
Screening takes place within 21 days before admission and subjects are admitted on Day -1. Dosing takes place on Day 1, after an overnight fast of at least 10 hours. Subjects remain fasted until 4 hours post-dose. There is a wash-out period of at least 14 days between each dose administration.
Subjects are discharged on Day 4 and return to the clinical unit on Days 5, 6, 7, 9 and 11 for outpatient assessments.
An End-of-Study Visit (ESV) takes place on Day 11 of Period 3 or within 7-14 days after discontinuation.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Male subject must agree to not donate semen from the day of first dosing until 3 months after last discharge and practice an effective contraceptive method with female sexual partners to prevent pregnancy.
- •Female subject must be of non-child bearing potential, i.e. postmenopausal, surgically sterilized, hysterectomy in medical history, or practicing highly effective non-hormonal birth control.
排除标准
- •Female subject who is pregnant, has been pregnant within 6 months before screening or breast-feeding within 3 months before screening.
- •Known or suspected hypersensitivity to solifenacin succinate, mirabegron or any components of the formulations used.
- •The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to admission to the clinical unit.
- •Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1.
研究组 & 干预措施
1: FDC-SET-SET
Fixed Dose Combination followed by two periods of the Single Entity Tablets
干预措施: solifenacin succinate (Drug)
1: FDC-SET-SET
Fixed Dose Combination followed by two periods of the Single Entity Tablets
干预措施: mirabegron (Drug)
1: FDC-SET-SET
Fixed Dose Combination followed by two periods of the Single Entity Tablets
干预措施: mirabegron/solifenacin succinate (Drug)
2: SET-FDC-FDC
Single Entity Tablets followed by two periods of Fixed Dose Combination
干预措施: solifenacin succinate (Drug)
2: SET-FDC-FDC
Single Entity Tablets followed by two periods of Fixed Dose Combination
干预措施: mirabegron (Drug)
2: SET-FDC-FDC
Single Entity Tablets followed by two periods of Fixed Dose Combination
干预措施: mirabegron/solifenacin succinate (Drug)
结局指标
主要结局
Pharmacokinetic parameter of solifenacin in plasma as measured by AUCinf (AUC extrapolated until infinity)
时间窗: Days 1-11
Pharmacokinetic parameter of solifenacin in plasma as measured by AUClast (AUC until last sample taken)
时间窗: Days 1-11
Pharmacokinetic parameter of mirabegron in plasma as measured by Cmax (Maximum concentration)
时间窗: Days 1-11
Pharmacokinetic parameter of solifenacin in plasma as measured by Cmax (Maximum concentration)
时间窗: Days 1-11
Pharmacokinetic parameter of mirabegron in plasma as measured by AUClast (AUC until last sample taken)
时间窗: Days 1-11
Pharmacokinetic parameter of mirabegron in plasma as measured by AUCinf (AUC extrapolated until infinity)
时间窗: Days 1-11
次要结局
- Pharmacokinetic profile of Solifenacin in plasma(Days 1-11)
- Pharmacokinetic profile of mirabegron in plasma(Days 1-11)
- Safety and tolerability of solifenacin succinate and mirabegron assessed by adverse events, vital signs, laboratory tests, physical examination and 12-lead electrocardiogram (ECG)(Screening to End of Study Visit (Day 11 Period 3 or within 7 to 14 days after discontinuation))