NCT04080609已完成1 期
A Single Dose, Open Label, Drug-drug Interaction Study to Investigate the Pharmacokinetics and Safety of Dorzagliation Administered Alone or in Combination With Rifampicin in Healthy Subjects
Hua Medicine Limited1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年3月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The purpose of this drug-drug interaction study is to investigate the impact of rifampicin on the pharmacokinetics of Dorzagliatin.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight ≥ 50 kg (male) or ≥ 45 kg (female)
- •BMI within 19～26 kg/m2
排除标准
- •History or disease status that may impact the ADME of the study
- •Use of any drugs, OTCs, or hebal within 4 weeks of screening
- •Drug abuse
- •Blood donation
研究组 & 干预措施
Sequential arm
Experimental
Dorzagliatin was administered single dose; after wash-out, rifampicin was dosed continuously for 9 days, with Dorzagliatin dosed simultaneously on day 8.
干预措施: Dorzagliatin (Drug)
结局指标
主要结局
Cmax
时间窗: up to 96 hours
Peak plasma concentration
AUClast
时间窗: up to 96 hours
Area under the plasma concentration curve
次要结局
未报告次要终点
研究者
研究点 (1)
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