NCT06619951已完成1 期
A Clinical Trial to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules 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
- 56
- 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 Single-center, Single-arm, Open, Fixed Sequence design to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult 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 6 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 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;
- •with A history of allergies, including medications, foods, mites, etc., or those known to be potentially allergic to drugs similar to the study drug, or those known to be allergic to itraconazole, rifampicin, or any 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;
研究组 & 干预措施
Group 1: VC004 and itraconazole
Experimental
干预措施: VC004 and Itraconazole (Drug)
Group 2: VC004 and rifampicin
Experimental
干预措施: VC004 and rifampicin (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: Day1-Day16
Maximum Observed Plasma Concentration (Cmax)
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
时间窗: Day1-Day16
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Second-line Treatment of Metastatic Colorectal CancerMetastatic Colorectal CancerNCT06242067Qilu Hospital of Shandong University50
招募中
1 期
Efficacy and Safety of CAR-T Cells Therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP)ITP - Immune ThrombocytopeniaNCT06352281920th Hospital of Joint Logistics Support Force of People's Liberation Army of China10
已完成
1 期
A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy ParticipantsHealthy ParticipantsNCT05932303Bristol-Myers Squibb47
尚未招募
1 期
Study to Evaluate the Drug-drug Interaction of JMKX001899 in Healthy SubjectsSolid Tumor, AdultNCT06348290Jemincare72
招募中
早期 1 期
An Exploratory Study of Efficacy and Safety of Iruplinalkib Tablets in Patients With ROS1 Positive Non-small Cell Lung CancerNon-Small Cell Lung CancerNCT06436885Henan Cancer Hospital39