A Phase 1, Open-Label, Three-Period, Single-center Study to Assess the Pharmacokinetic Interactions Between ZSP1273 and Oseltamivir in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Plasma pharmacokinetics
研究概览
简要总结
To evaluate the drug-drug interaction between ZSP1273 and oseltamivir, the pharmacokinetic characteristics and safety of ZSP1273 and oseltamivir in healthy subjects, so as to provide a basis for the design of administration regimen in subsequent clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and female subjects between 18-45 years (Both inclusive);
- •Body weight is no less than 50kg in males and no less than 45kg in females.Body mass index (BMI) 18~26 kg/m2 (Both inclusive); BMI is determined by the following equation: BMI = weight/height2 (kg/m2);
- •Subjects (including partners) are willing to voluntarily use effective contraception from screening to 3 months after the last study drug administration.
排除标准
- •Known history of allergic constitution (multiple drugs especially with ZSP1273 or oseltamivir and its preparation of the main ingredient allergy, food allergy);
- •Subjects who donated blood or bleeding profusely(> 450 mL)in the 3 months preceding study screening;
- •History or presence of any disease or condition known to increase the risk of bleeding, eg.hemorrhoids, acute gastritis or gastric and duodenal ulcer, etc;
- •Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal within 14 days prior to screening;
- •Concomitant therapy with any drugs with known hepatic enzyme-inducing or inhibiting agents that may change the activity of drug metabolic enzymes ，is intended to be taken in combination 28 days prior to screening or during the study period；
- •Participated in another clinical research study or received any investigational products within 3 months prior to dosing;
- •Presence of clinically significant abnormalities in ECG , QTcB>450ms in males,or QTcB>470ms in females;
- •Any of the following diseases (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, tumor, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular diseases) that are clinically significant in clinical laboratory examination or other clinical findings within 6 months prior to screening;
- •Breast-feeding women or those with positive pregnancy test results;
- •Subjects who should not be included in the study in the opinion of the Investigator.
研究组 & 干预措施
sequence 1
Period 1: study of ZSP1273's pharmacokinetics at steady state； Period 2: study of Oseltamivir's pharmacokineticsat at steady state； Period 3: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state.
干预措施: ZSP1273 (Drug)
sequence 1
Period 1: study of ZSP1273's pharmacokinetics at steady state； Period 2: study of Oseltamivir's pharmacokineticsat at steady state； Period 3: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state.
干预措施: Oseltamivir (Drug)
sequence 2
Period 1: study of Oseltamivir's pharmacokineticsat at steady state; Period 2: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state; Period 3: study of ZSP1273's pharmacokinetics at steady state.
干预措施: ZSP1273 (Drug)
sequence 2
Period 1: study of Oseltamivir's pharmacokineticsat at steady state; Period 2: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state; Period 3: study of ZSP1273's pharmacokinetics at steady state.
干预措施: Oseltamivir (Drug)
sequence 3
Period 1: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state; Period 2: study of ZSP1273's pharmacokinetics at steady state; Period 3: study of Oseltamivir's pharmacokineticsat at steady state.
干预措施: ZSP1273 (Drug)
sequence 3
Period 1: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state; Period 2: study of ZSP1273's pharmacokinetics at steady state; Period 3: study of Oseltamivir's pharmacokineticsat at steady state.
干预措施: Oseltamivir (Drug)
结局指标
主要结局
Plasma pharmacokinetics
时间窗: pre-dose and up to 72hours post-dose
CL/F
Number of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE)
时间窗: up to 37days
TEAEs will be summarized displaying the number of TEAEs along with the number and percentage of participants with at least one TEAE according to: Number of AEs, Severity and relation to study drug.
次要结局
未报告次要终点