A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Cmax: Maximum plasma concentration. Blood samples will be collected.
研究概览
简要总结
To evaluate the pharmacokinetic characteristics of HR091506 tablets in different batches in healthy subjects after single administration.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female between the ages of 18 and 50 years, inclusive.
- •At least 50.0 kg for male subjects, 45.0 kg for female subjects, with a Body Mass Index (BMI) between 19.0-26.0 kg/m2, inclusive (BMI = weight/height2).
- •Prior to screening, during the trial, and for 90 days after the last administration, subjects (including male subjects) must not have plans to conceive and must voluntarily adopt effective contraceptive measures.
- •Subjects who could understand the nature, significance, potential benefits, inconvenience, and potential risks of the study, understand the procedures and methods, be willing to complete the trial strictly following the protocol, and voluntarily sign the informed consent.
排除标准
- •Subjects with history of drug or food allergies.
- •Subjects with a history of diseases related to the circulatory, endocrine, nervous, digestive, respiratory, hematolymphatic, immune, mental, skin, bone, muscle, urogenital, mucosal, and metabolic systems.
- •Use of any medication within 14 days prior to dosing.
- •Subjects who have taken any clinical investigational products or participated in the clinical research of medical devices within 90 days before the trial, or plan to participate in other clinical trials during the study.
- •Subjects who have donated blood or experienced blood loss greater than 300 mL, or have received a blood transfusion or used blood products within 90 days prior to screening.
- •Subjects who take more than 5 cigarettes per day on average within 90 days prior to the study or do not agree to prohibit smoking during the study.
研究组 & 干预措施
Sequence 1
Period 1: HR091506 tablet T1 Period 2: HR091506 tablet T2 Period 3: HR091506 tablet R
干预措施: HR091506 tablet (Drug)
Sequence 2
Period 1: HR091506 tablet T2 Period 2: HR091506 tablet R Period 3: HR091506 tablet T1
干预措施: HR091506 tablet (Drug)
Sequence 3
Period 1: HR091506 tablet R Period 2: HR091506 tablet T1 Period 3: HR091506 tablet T2
干预措施: HR091506 tablet (Drug)
Sequence 4
Period 1: HR091506 tablet T2 Period 2: HR091506 tablet T1 Period 3: HR091506 tablet R
干预措施: HR091506 tablet (Drug)
Sequence 5
Period 1: HR091506 tablet T1 Period 2: HR091506 tablet R Period 3: HR091506 tablet T2
干预措施: HR091506 tablet (Drug)
Sequence 6
Period 1: HR091506 tablet R Period 2: HR091506 tablet T2 Period 3: HR091506 tablet T1
干预措施: HR091506 tablet (Drug)
结局指标
主要结局
Cmax: Maximum plasma concentration. Blood samples will be collected.
时间窗: From 0 hour predose up to 36 hours postdose
AUC0-t: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
时间窗: From 0 hour predose up to 36 hours postdose
AUC0-∞: Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
时间窗: From 0 hour predose up to 36 hours postdose
Tmax: Observed time to reach Cmax. Blood samples will be collected.
时间窗: From 0 hour predose up to 36 hours postdose
次要结局
- Incidence of treatment emergent AEs (TEAEs)(From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 24))