NCT07533851已完成1 期
A Food Effect Study of 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
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
This study will adopt a randomized, open-label, two-period, 2-way crossover design to evaluate Food effect of VC005 Tablets in healthy subjects
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
- •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;
- •History of sensitivity to drugs similar to the study drug;allergic constitution (e.g. allergy to two or more kinds of drugs and food );
- •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
GK
Experimental
干预措施: VC005 Tablets (Drug)
KG
Experimental
干预措施: VC005 Tablets (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: Day1-Day7
Area under the plasma concentration-time curve(AUC）
时间窗: Day1-Day7
次要结局
未报告次要终点
研究者
研究点 (1)
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