NCT00902681已完成1 期
An Open-Label, Randomized, Single-Dose, Two-Way Crossover Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz™), Manufactured At Zwickau Versus Vega Baja, In Healthy Subjects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- AUCinf, AUClast, and Cmax of 5-HMT
研究概览
简要总结
This bioequivalence (BE) study is to satisfy FDA regulatory requirements for extended releases drug product transfer from Zwickau, Germany to Vega Baja, Puerto-Rico.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Healthy male and/or female subjects
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
排除标准
- •Subjects with evidence or history of clinically significant urologic diseases
- •A positive urine drug screen
- •Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method
研究组 & 干预措施
Reference
Other
a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Zwickau
干预措施: Fesoterodine (Drug)
Test
Other
a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Vega Baja (Test)
干预措施: Fesoterodine (Drug)
结局指标
主要结局
AUCinf, AUClast, and Cmax of 5-HMT
时间窗: 6 weeks
次要结局
- Tmax and half-life of 5-HMT as data permit.(6 weeks)
- Safety laboratory tests and adverse events(6 weeks)
研究者
研究点 (1)
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