An Open-Label, Single-Dose, Randomized, Cross-Over Study To Estimate The Bioavailability And Food Effect Of 4 Mg Fesoterodine Extended Release Beads-In-Capsule Formulations Compared To Commercial Tablet Formulation In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])
研究概览
简要总结
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
详细描述
To estimate the bioavailability of three different 4 mg fesoterodine ER beads-incapsule formulations compared to 4 mg fesoterodine marketed ER tablets under fasting and fed conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 between the ages of 18 and 55 years
排除标准
- •Evidence or history of clinically significant disease
研究组 & 干预措施
D
4 mg fesoterodine 20% coated ER beads in capsule under fasting condition.
干预措施: fesoterodine (Drug)
A
4 mg fesoterodine IR beads in capsule under fasting condition
干预措施: fesoterodine (Drug)
B
4 mg fesoterodine 10% coated ER beads in capsule under fasting condition
干预措施: fesoterodine (Drug)
C
4 mg fesoterodine 15% coated ER beads in capsule under fasting condition.
干预措施: fesoterodine (Drug)
E
4 mg fesoterodine ER tablets under fasting condition.
干预措施: fesoterodine (Drug)
F
4 mg fesoterodine TBD % coated ER beads in capsule under fed condition.
干预措施: fesoterodine (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT.
Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose
次要结局
- Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose)
- Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose)