A Phase 1, Open-Label, Two-Period，Drug Interaction Study Assess the Effects of ZSP1273 Tablets on the Pharmacokinetics of Warfarin and Midazolam
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- S-warfarin Maximum Plasma Concentration [Cmax]
研究概览
简要总结
This study is a single-center, open label phase I clinical study to characterize the DDIs potential of ZSP1273 With Warfarin and Midazolam in Chinese healthy participants. This study also aims to evaluate the safety and tolerability of ZSP1273 in the presence of Warfarin and Midazolam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult, male and female participants, 18 to 55 years of age, inclusive, at first Check-In Visit;
- •Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight >50 kg(male) or >45kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
- •Ability to understand and willingness to sign a written informed consent form;
- •Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant.
排除标准
- •Participants with a history of hypersensitivity to study drug(ZSP1273,warfarin, midazolam) or any component of study medication;
- •Participants with a history of and/or signs and symptoms of current abnormal hemostasis or blood dyscrasia or abnormal prothrombin time (PT), international normalized ratio (INR), or activated partial thromboplastin time at screening;
- •Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period;
- •Participants who donated blood/bleeding profusely (> 400 mL) 3 months prior to randomization;
- •Those with clinically significant ECG abnormalities, or QTcF > 450ms in men and QTcF > 470ms in women;
- •Participants who test positive at screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Syphilis spirochete-specific antibodies (TPPA);
- •Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
- •Females who are pregnant, lactating, or likely to become pregnant during the study.
- •History of dysphagia or any gastrointestinal disorder that affect absorption
研究组 & 干预措施
The DDI of ZSP1273 ,Warfarin and Midazolam
Warfarin and midazolam will be co-administered alone and in combination with ZSP1273.
干预措施: ZSP1273 (Drug)
结局指标
主要结局
S-warfarin Maximum Plasma Concentration [Cmax]
时间窗: Day1 to Day28
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of S-warfarin
Midazolam Maximum Plasma Concentration [Cmax]
时间窗: Day1 to Day28
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of midazolam and its active metabolite alpha-hydroxymidazolam
S-warfarin Area under the curve[AUC0-inf]
时间窗: Day1 to Day28
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of S-warfarin
Midazolam Area under the curve[AUC0-inf]
时间窗: Day1 to Day28
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of midazolam and its active metabolite alpha-hydroxymidazolam
次要结局
- Number of participants with adverse events and serious adverse events(Day1 to Day28)