A Open-Label, Two-sequence Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of ZSP1273 With Digoxin, Rosuvastatin,Itraconazole and Probenecid in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Pharmacokinetic - Cmax
研究概览
简要总结
The drug-drug interaction study had been designed to investigate the effect of ZSP1273 on the pharmacokinetics of digoxin, Rosuvastatin and the effect of Itraconazole and Probenecid on the pharmacokinetics of ZSP1273
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •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, 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,Digoxin, Rosuvastatin,Itraconazole ) or any component of study medication;
- •Participants had taken prescription, over-the-counter, herbal, or vitamin products within 28 days prior to 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 Electrocardiogram(ECG) abnormalities, or QTcF > 450ms;
- •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
Experimental 1
All participants will receive the following oral doses of study drugs following an overnight fast in the fixed-sequence below:
Period 1: 1 × 0.25-mg digoxin tablet, 1 × 10-mg rosuvastatin tablet Period 2: 8 × 600-mg ZSP1273 tablet+1 × 0.25 mg digoxin tablet, 1 × 10-mg rosuvastatin tablet
干预措施: Digoxin (Drug)
Experimental 1
All participants will receive the following oral doses of study drugs following an overnight fast in the fixed-sequence below:
Period 1: 1 × 0.25-mg digoxin tablet, 1 × 10-mg rosuvastatin tablet Period 2: 8 × 600-mg ZSP1273 tablet+1 × 0.25 mg digoxin tablet, 1 × 10-mg rosuvastatin tablet
干预措施: Rosuvastatin (Drug)
Experimental 1
All participants will receive the following oral doses of study drugs following an overnight fast in the fixed-sequence below:
Period 1: 1 × 0.25-mg digoxin tablet, 1 × 10-mg rosuvastatin tablet Period 2: 8 × 600-mg ZSP1273 tablet+1 × 0.25 mg digoxin tablet, 1 × 10-mg rosuvastatin tablet
干预措施: ZSP1273 (Drug)
Experimental 2
All participants will receive the following oral doses of study drugs following an overnight fast in the fixed-sequence below:
Period 1: 600-mg ZSP1273 tablet Period 2: 5× 500mg Probenecid tablet BID+600-mg ZSP1273 tablet Period3: （Day1）200mg Itraconazole Capsule BID，（Day2-7）200mg Itraconazole Capsule QD+600-mg ZSP1273 tablet
干预措施: ZSP1273 (Drug)
Experimental 2
All participants will receive the following oral doses of study drugs following an overnight fast in the fixed-sequence below:
Period 1: 600-mg ZSP1273 tablet Period 2: 5× 500mg Probenecid tablet BID+600-mg ZSP1273 tablet Period3: （Day1）200mg Itraconazole Capsule BID，（Day2-7）200mg Itraconazole Capsule QD+600-mg ZSP1273 tablet
干预措施: Itraconazole (Drug)
Experimental 2
All participants will receive the following oral doses of study drugs following an overnight fast in the fixed-sequence below:
Period 1: 600-mg ZSP1273 tablet Period 2: 5× 500mg Probenecid tablet BID+600-mg ZSP1273 tablet Period3: （Day1）200mg Itraconazole Capsule BID，（Day2-7）200mg Itraconazole Capsule QD+600-mg ZSP1273 tablet
干预措施: Probenecid (Drug)
结局指标
主要结局
Pharmacokinetic - Cmax
时间窗: 0-168 hours
Maximum observed plasma concentration
Pharmacokinetic -Area under the curve（AUC）
时间窗: 0-168 hours
Area under the curve
次要结局
- Number of participants with adverse events(Day1 to Day30)