CTRI/2009/091/000723未知1 期
An open label, randomized, three period, single-dose, crossover study to determine the bioavailability of 300 mg aliskiren mini-tablets relative to the 300 mg aliskiren market tablet under fasted condition and to evaluate the effect of food on the pharmacokinetics of 300 mg aliskiren minitablets in healthy subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- To determine the bioavailability of a single oral dose of 300 mg aliskiren mini-tablets relative to the 300 mg aliskiren market tablet under fasted condition in healthy subjectsTo evaluate the effect of food on the pharmacokinetics of a single oral dose of 300 mg aliskiren mini-tablets in healthy subjects
研究概览
简要总结
暂无简介。
研究设计
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
入选标准
- •Healthy male and female subjects ( women of non-child bearingpotential).
排除标准
- •Female subjects of child bearing potential.
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
结局指标
主要结局
To determine the bioavailability of a single oral dose of 300 mg aliskiren mini-tablets relative to the 300 mg aliskiren market tablet under fasted condition in healthy subjectsTo evaluate the effect of food on the pharmacokinetics of a single oral dose of 300 mg aliskiren mini-tablets in healthy subjects
时间窗: Single Dose Of SPP100 AdministrationUnder Fasting Or Fed Condition FollowedBy PK Sample Collection Till Day 8(Except On Day 6)
次要结局
- To evaluate the safety and tolerability of a single oral dose of 300 mg aliskiren mini-tablets administered with or without meal and a single oral dose of 300 mg aliskiren market tablet in healthy subjects without meal, respectively.(Number Of AEs From First Dosing To End Of Study Evaluation And Number Of SAEs From Date Of ICF To 4weeks After Last Dose Administration. Safety assessments will also include vital signs, blood pressure and pulse rate) standard clinical laboratory evaluations. Blood pressure, pulse rate: screening*, each baseline*, pre- dose* and 2, 4, 12 and 24* hours post dose, end of study* Note: measurements are supine, or supine and after 3 min standing if indicated by an *asterisk) Hematology; Blood chemistry; Urinalysis: screening, each baseline, end of study)
研究者
研究点 (1)
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