NCT00609596已完成1 期
An Open Label, Randomized, Repeat Dose, 3 Period Crossover Study to Determine the Bioequivalence of 3 Different Formulations of Tamsulosin at Steady State in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- PK at 0,1,2,3,4,5,6,7,8,10,12,16,24,36,48,72
研究概览
简要总结
Dutasteride and tamsulosin are to treat benign prostatic hyperplasia. Studies show that when given together, there is more improvement in symptoms than either drug alone. In this study, we are looking to see if 2 different formulations of tamsulosin in our combination capsules are the same after 7 days of dosing as the US commercial tamsulosin and dutasteride.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Other
干预措施: GI198745 (Drug)
结局指标
主要结局
PK at 0,1,2,3,4,5,6,7,8,10,12,16,24,36,48,72
次要结局
- Clinical safety labs(at check in)
- measurement of orthostatic hypotension(at 6 hours post dose on days 1 and 7)
- adverse event reporting
- C(tau) (pre-dose concentrations determined immediately before a dose at steady state), t1/2, tmax, lambda, Cmin and fluctuation [(Cmax - Cmin)/(AUC(0-24)/24)] of tamsulosin, as data permit.
- Safety and tolerability of all treatments as assessed by blood pressure and pulse rate measurements, adverse events and clinical laboratory safety tests.
研究者
研究点 (1)
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