An Open-Label, Dose-Escalating Study Of The Pharmacokinetics, Safety And Tolerability Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Absorption Rate Constant (Ka)
研究概览
简要总结
The purpose of the study is to evaluate the pharmacokinetics, safety, and tolerability of fesoterodine following administration to pediatric patients, aged 8-17 years, with overactive bladder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A total body weight >25 kg (55 lbs).
- •Symptoms of urinary frequency (average ≥8 daily bathroom visits to urinate) and urgency to urinate, with or without urgency incontinence, for at least 6 months prior to enrolment, OR
- •Stable neurological disease and urodynamically confirmed detrusor overactivity, who may require intermittent catheterization for management of urinary drainage.
排除标准
- •Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, before first study dose
- •Ongoing use of potent CYP3A4 inhibitors or inducers or CYP2D6 inhibitors
- •Ongoing use of another drug for treating overactive bladder
- •Uncontrolled narrow angle glaucoma, urinary or gastric retention
研究组 & 干预措施
Fesoterodine once daily
干预措施: Fesoterodine (Drug)
结局指标
主要结局
Absorption Rate Constant (Ka)
时间窗: Day 28 and Day 56
Apparent Volume of Distribution (VC/F)
时间窗: Day 28 and Day 56
The volume necessary to account for the total amount of drug in the body if it were present throughout the body at the same concentration found in the blood. Estimated using non linear mixed effect modeling.
Area Under the Plasma Drug Concentration Time Curve (AUC)
时间窗: Day 28 and Day 56
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Maximum Observed Plasma Concentration (Cmax)
时间窗: Day 28 and Day 56
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: Day 28 and Day 56
Plasma Decay Half-Life (t1/2)
时间窗: Day 28 and Day 56
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Apparent Oral Clearance (CL/F)
时间窗: Day 28 and Day 56
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated using non linear mixed effect modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
次要结局
- Post-void Residual (PVR) Volume(Baseline, Week 4, and Week 8 post-dose)