Single-dose, Open-label, Randomized, Crossover Bioavailability Study of 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273 Under Fasted Condition in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from time zero to infinity (AUCinf)
研究概览
简要总结
The purpose of this study is to establish bioavailability of 2 treatments with ZSP1273: 200mg tablets and 200mg granules will be given to healthy Participants under fasting conditions.
Bioavailability will be evaluated and verified on the basis of pharmacokinetic data.
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 50 Years（Adult）
- 性别
- Male
- 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 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 an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
- •Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 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
ZSP1273 Sequence 1
Single oral dose of 200mg ZSP1273 tablet administered under fasting conditions in first period and 200mg granules in second period，then 200mg ZSP1273 tablet administered under fasting conditions in third period and 200mg granules in fourth period.
干预措施: ZSP1273 tablet (Drug)
ZSP1273 Sequence 1
Single oral dose of 200mg ZSP1273 tablet administered under fasting conditions in first period and 200mg granules in second period，then 200mg ZSP1273 tablet administered under fasting conditions in third period and 200mg granules in fourth period.
干预措施: zsp1273 granules (Drug)
ZSP1273 Sequence 2
Single oral dose of 200mg ZSP1273 granules administered under fasting conditions in first period and 200mg tablet in second period，then 200mg ZSP1273 granules administered under fasting conditions in third period and 200mg tablet in fourth period.
干预措施: ZSP1273 tablet (Drug)
ZSP1273 Sequence 2
Single oral dose of 200mg ZSP1273 granules administered under fasting conditions in first period and 200mg tablet in second period，then 200mg ZSP1273 granules administered under fasting conditions in third period and 200mg tablet in fourth period.
干预措施: zsp1273 granules (Drug)
结局指标
主要结局
Area under the concentration-time curve from time zero to infinity (AUCinf)
时间窗: Day 1 to Day 20
The AUCinf of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.
Maximum observed plasma concentration (Cmax)
时间窗: Day 1 to Day 20
The Cmax of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.
Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)
时间窗: Day 1 to Day 20
The AUClast of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.
次要结局
- Number of participants with drug-related adverse events as assessed by CTCAE v5.0(Day 1 to Day 20)