NCT04080596已完成1 期
A Single Dose, Open Label, Drug-drug Interaction Study to Investigate the Pharmacokinetics, Pharmadynamics and Safety of HMS5552 Administered Alone or in Combination With Itraconazole in Patients With Type 2 Diabetes Mellitus
Hua Medicine Limited1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年10月13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
- 18
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The purpose of this study is to investigate the impact of itraconzaole 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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-65
- •Body weight ≥ 50 kg
- •BMI ≥ 19.0 kg/m2 and ≤ 30.0 kg/m2
- •HbA1c ≥ 7% and ≤ 10.5%
- •FPG ≥ 7.5 mmol/L and ≤ 13.3 mmol/L
排除标准
- •Use of prescription or OTC medications, and herbal within 14 days prior to dosing
- •Blood donation
- •Any surgery or treatment that may impact the ADME of the drug
研究组 & 干预措施
Sequential arm
Experimental
Dorzagliatin administered alone on Day 1; after wash-out, intraconazole was administered from Day 8 to Day 15, with Dorzagliatin administered together on Day 11.
干预措施: Dorzagliatin (Drug)
结局指标
主要结局
Cmax
时间窗: up to 96 hours
Peak concentration
AUClast
时间窗: up to 96 hours
Area under the curve
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Evaluate the Effect of Itraconazole on JNJ-56136379 in Healthy Adult ParticipantsHealthyNCT03945539Janssen Sciences Ireland UC16
已完成
1 期
Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy SubjectsHealthyNCT04843449Ascletis Pharmaceuticals Co., Ltd.24
已完成
1 期
DDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.HealthyNAFLDNCT04845646Gannex Pharma Co., Ltd.24
已完成
1 期
A Itraconazole Effect Study of SHR2554 on Healthy Chinese Adult SubjectsHealthy Adult SubjectsNCT04627129Jiangsu HengRui Medicine Co., Ltd.18
已完成
1 期
A Drug-Drug Interaction Study to Evaluate the Effect of Itraconazole on the Pharmacokinetic Profile of Etrumadenant in Healthy Adult ParticipantsHealthy ParticipantsNCT05154136Arcus Biosciences, Inc.20