A Randomized, Open-label, Crossover, Pharmacokinetic and Pharmacodynamic Study of Z-215 Compared With Rabeprazole Sodium in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 主要终点
- 24-Hour Intragastric pH Profile
研究概览
简要总结
The purpose of this study is to evaluate pharmacokinetics and pharmacodynamics of Z-215 (10 mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium (10 mg, 20 mg ) in Healthy Male Subjects. And to evaluate food-effect in Healthy Male Subjects administrated Z-215 20 mg.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Has negative results for H. pylori IgG antibody at screening.
- •A body mass index 18.5≦BMI<25.0 kg/m^2 at screening.
- •Able to understand the consent of the study and comply with the study. Able to give informed consent in writing before participating in the study.
排除标准
- •Has a history of PPI allergy.
- •Has a history of drug or food serious allergy.
- •Presently has or has a history of diseases that may affect evaluation of the study results such as gastrointestinal, hepatic, renal, respiratory, endocrine, blood, cardiovascular, mental or congenial metabolic disease.
- •Has a history of surgery (such as resection of the liver, kidney, or digestive tract) that may affect the pharmacokinetics of the study drug.
- •History of previous and current acid-related diseases.
- •Received H. pylori eradication treatment within 6 months before screening.
- •Has 450msec<QTC by Fridericia test at screening ECG .
- •Has hypoacidity or anacidity. Or be determined that low gastric acid or no stomach acid by the gastric pH monitoring at baseline period.
- •History or suspicion of drug, opioid, alcohol abuse or positive screening results.
- •Use of any prescription drugs within 4 weeks prior to baseline period.
- •Use of any over-the-counter drugs within 2 weeks prior to baseline period.
- •Received blood transfusions within 12 weeks or donated ≥400mL of whole blood within 12 weeks or ≥200mL of whole blood within 4 weeks prior to baseline period. Donated platelet or plasma within 2 weeks prior to baseline period.
研究组 & 干预措施
2
3-way cross-over, Z-215 20 mg/day / Z-215 40 mg/day / Rabeprazole Sodium 20 mg/day
干预措施: Z-215 20mg (Drug)
2
3-way cross-over, Z-215 20 mg/day / Z-215 40 mg/day / Rabeprazole Sodium 20 mg/day
干预措施: Rabeprazole Sodium 20mg (Drug)
1
3-way cross-over, Z-215 10 mg/day / Z-215 20 mg/day / Rabeprazole Sodium 10 mg/day
干预措施: Z-215 10mg (Drug)
1
3-way cross-over, Z-215 10 mg/day / Z-215 20 mg/day / Rabeprazole Sodium 10 mg/day
干预措施: Z-215 20mg (Drug)
1
3-way cross-over, Z-215 10 mg/day / Z-215 20 mg/day / Rabeprazole Sodium 10 mg/day
干预措施: Rabeprazole Sodium 10mg (Drug)
3
3-way cross-over, Z-215 20 mg/day (before breakfast) / Z-215 20 mg/day (after breakfast) / Rabeprazole Sodium 10 mg/day (after breakfast)
干预措施: Z-215 20mg (Drug)
3
3-way cross-over, Z-215 20 mg/day (before breakfast) / Z-215 20 mg/day (after breakfast) / Rabeprazole Sodium 10 mg/day (after breakfast)
干预措施: Rabeprazole Sodium 10mg (Drug)
结局指标
主要结局
24-Hour Intragastric pH Profile
时间窗: 4 weeks
Summary statistics of the measurements on Day1 and Day5 of administration are to be calculated by dose.
tmax: Time to Reach Maximum Plasma Concentration (Cmax) for Z-215
时间窗: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Rac(AUC): Accumulation Index of AUC (Rac(AUC)) for Z-215
时间窗: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Cmax: Maximum Plasma Concentration for Z-215
时间窗: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
t1/2: Terminal Elimination Half-life (t1/2) for Z-215
时间窗: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
AUC0-∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Z-215
时间窗: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
CL/F: Apparent Total Body Clearance (CL/F) Pharmacokinetic Parameter for Z-215
时间窗: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Vd/F: Apparent Volume of Distribution (Vd/F) Pharmacokinetic Parameter for Z-215
时间窗: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
MRT0-∞: Mean Residence Time from Time 0 to Infinity for Z-215
时间窗: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Rac(Cmax): Accumulation Index of Cmax (Rac(Cmax)) for Z-215
时间窗: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Lambda Z: Terminal Elimination Rate Constant (Lambda Z) for Z-215
时间窗: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Z-215
时间窗: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
AUC0-24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 hour for Z-215
时间窗: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
次要结局
未报告次要终点