NCT07796191尚未招募1 期
A Clinical Trial of Drug-drug Interactions for VC005 Tablets in Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
研究概览
简要总结
This study includes three groups of Drug-Drug Interaction( DDI ) studies:
- To evaluate the effect of verapamil on the pharmacokinetics of a single oral dose of VC005 in healthy subjects;
- To evaluate the effect of probenecid on the pharmacokinetics of a single oral dose of VC005 in healthy subjects;
- To evaluate the effect of VC005 on the pharmacokinetics of a single oral dose of metformin tablets in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Able and willing to give written informed consent before study, and fully understand the study content, process and possible adverse reactions;
- •Able to complete the study in compliance with the protocol;
- •Subject (including partner) is willing to voluntarily take effective contraceptive measures from screening through 3 months after the last dose of study drug ；
- •Male and female subjects between the ages of 18 and 45 years, inclusive;
- •At least 50.0kg for male subjects, 45.0kg for female subjects, with a Body Mass Index (BMI= Weight/Height2) between 19.0-26.0 kg/m2, inclusive;
排除标准
- •More than 5 cigarettes per day on average within 3 months prior to screening;
- •Subjects with a history of allergy, including allergy to drugs, food, dust mites, etc., or known hypersensitivity to drugs of the same class as the investigational product, or known hypersensitivity to verapamil, probenecid, metformin, or any of the excipients;
- •History of drug and/or alcohol abuse (alcoholism defined as: drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); history of drug abuse or or have used drugs within the past five years;
- •Donation or loss of a significant volume of blood (> 400 mL) within 3 months prior to screening;
- •History of difficulties in swallowing or any history of gastrointestinal, liver, kidney disease (whether cured or not) or surgery that affects drug absorption or excretion；
- •Intake of any prescription drugs, over-the-counter drugs, vitamin or herbal medicine within 14 days prior to receiving study drug;
研究组 & 干预措施
VC005 and probenecid
Experimental
干预措施: VC005 and probenecid (Drug)
VC005 and metformin
Experimental
干预措施: VC005 and metformin (Drug)
VC005 and verapamil
Experimental
干预措施: VC005 and verapamil (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
时间窗: Day1-Day12
Maximum Observed Plasma Concentration (Cmax)
时间窗: Day1-Day12
次要结局
未报告次要终点
研究者
研究点 (1)
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