A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of tolterodine
研究概览
简要总结
A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules
详细描述
Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules
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
- 21 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 21 and 55 years, inclusive
排除标准
- •Evidence or history of clinically significant diseases
研究组 & 干预措施
A
4 mg tolterodine extended release capsules, administered with water and under fasting condition.
干预措施: tolterodine tartrate (Drug)
B
4 mg microspheres in powder blend release rate 2 (MPB-RR2), administered without water and under fasting condition.
干预措施: tolterodine tartrate (Drug)
C
4 mg microspheres in powder blend release rate 1 (MPB-RR1), administered without water and under fasting condition.
干预措施: tolterodine tartrate (Drug)
D
4 mg MPB-RR1, administered without water and under fed condition.
干预措施: tolterodine tartrate (Drug)
E
4 mg MPB-RR1, administered with water and under fasting condition.
干预措施: tolterodine tartrate (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of tolterodine
时间窗: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of tolterodine
时间窗: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
次要结局
- Plasma Decay Half-Life (t1/2) of tolterodine(0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of 5-HMT(0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose)
- Maximum Observed Plasma Concentration (Cmax) of 5-HMT(0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of 5-HMT(0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of tolterodine.(0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of 5-HMT(0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of tolterodine(0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose)
- Plasma Decay Half-Life (t1/2) of 5-HMT(0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose)