NCT07565597进行中（未招募）1 期
A Single-dose, Randomized, Open-label, Four-period, Replicate Crossover, Comparative Pharmacokinetic Study of Two Formulations of Gecacitinib Hydrochloride Tablets in Healthy Adult Participants Under Fasting Conditions.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) Of Gecacitinib and its main metabolite ZG0244
研究概览
简要总结
This study will compare the pharmacokinetics (PK) effect of two different formulations of Gecacitinib Hydrochloride Tablets in healthy Adult participants
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18≤ age ≤ 45, male or female;
- •Body weight: ≥50 kg for male, ≥45 kg for female; body mass index (BMI): 19.0-26.0 kg/m^2 (inclusive);
- •Informed consent will be signed before the trial, and the content, process and possible adverse reactions of the study will be fully understood;
- •The volunteers should be able to communicate well with the researchers and understand and comply with the requirements of the study.
排除标准
- •Participants who were enrolled in a clinical trial or used a study drug within 3 months before administration of the study drug.
- •Participants may not be able to complete the study for other reasons or have other reasons for not participating in the study as judged by the investigator.
研究组 & 干预措施
Test Group
Experimental
Participants will take a single Gecacitinib 75mg Tablet under fasting condition
干预措施: Gecacitinib Hydrochloride Tablets (Drug)
Reference Group
Experimental
Participants will take a single Gecacitinib 75mg Tablet under fasting condition
干预措施: Gecacitinib Hydrochloride Tablets (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) Of Gecacitinib and its main metabolite ZG0244
时间窗: up to 48 hours
Gecacitinib and its main metabolite ZG0244 AUC(0-t)
时间窗: up to 48 hours
Gecacitinib and its main metabolite ZG0244 AUC(0-inf)
时间窗: up to 48 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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