NCT00719758已完成1 期
TRK-100STP Pharmacokinetic Study in Healthy Volunteers - Evaluation of Pharmacokinetic Interaction Between TRK-100STP and Kremezin
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
- 主要终点
- Pharmacokinetic profile
研究概览
简要总结
The purpose of this study is to evaluate the effect of AST-120 on the PK of TRK-100STP, and to evaluate the safety and tolerability of TRK-100STP alone or in combination with AST-120
详细描述
Non-blinded, randomized and crossover study to evaluate pharmacokinetic interaction between TRK-100STP and AST-120 in different administration condition. Nonelderly adult volunteers will receive TRK-100STP with or without AS-T120 after meal. Safety parameters will concurrently be measured.
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
- 20 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of written informed consent
- •Body Mass Index (BMI) of ≥17.6 to ≤26.4 kg/m2 and weight of ≥50 to ≤80 kg
排除标准
- •Clinical abnormal physical findings, including BP, pulse rate, ECG and laboratory assessments
- •Receives any investigational medicine within 120 days before screening
- •Recent blood donor
研究组 & 干预措施
1
Experimental
Cross-over study
干预措施: TRK-100STP (BERASUS LA) (Drug)
1
Experimental
Cross-over study
干预措施: AST-120 (Kremezin®) (Drug)
结局指标
主要结局
Pharmacokinetic profile
时间窗: 1 day
次要结局
- Safety parameters (vital signs, ECG, laboratory tests)(1 day)
研究者
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