NCT07113054进行中（未招募）1 期
A Clinical Trial to Evaluate the Effect of Grapefruit Juice on the Pharmacokinetics and Pharmacodynamics of Edoxaban in Healthy Adults
Hyewon Chung1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2025年9月2日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- AUCinf
研究概览
简要总结
The aim of the study is to evaluate the effect of grapefruit juice on the pharmacokinetics and pharmacodynamics of edoxaban in healthy adults
详细描述
Pharmacokinetics and pharmacodynamics of edoxaban without coadministration of grapefruit juice will be compared with those after administration of grapefruit juice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 19 to 50 years of age (inclusive) at the time of screening
- •Subjects with BMI of 18 to 32 kg/m2 (inclusive)
- •Subjects who agree to use medically acceptable methods of contraception and not to donate sperm or oocyte
- •Subjects who voluntarily decided to participate in the study and provided written consent to comply with the protocol
排除标准
- •Subjects with current or history of clinically significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, or neuropsychiatric disease
- •Subjects with current or history of clinically significant hypersensitivity reactions or hypersensitivity reactions to the components or constituents of the investigational product
- •Subjects who have clinically significant hemorrhage or increased risk of hemorrhage due to the following conditions A. Recent history of gastrointesinal ulcers B. Malignant tumor with a high risk of bleeding C. Recent brain or spinal cord injury D. Recent brain, spinal cord, or opthalmic surgery E. Recent history of intracranial or intracerebral hemorrhage F. Esophageal varices, arterial malformations, vascular aneurysms, or spinal cord or cerebral vascular abnormalities G. Coagulation disorders, thrombocytopenia, or platelet dysfunction H. Recent biopsy or major trauma I. Bacterial endocarditis J. Esophagitis, Gastritis, or Gastroesophageal reflux
- •Subjects with a history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •Subjects whose eGFR calculated by the CKD-EPI formula is 80mL/min or less at Screening
- •Subjects whose AST or ALT levels are more than 2 times the upper limit of normal range, or total bilirubin levels are more than 1.5 times the upper limit of normal range at screening
- •Subjects whose coagulation test (aPTT, PT) exceeds the normal range at screening
- •Subjects who have taken the following medication or medication known to have significant drug interactions with the investigational product within the 2 weeks prior to the first administration day A. Strong P-gp inhibitor or inducer B. Acetylsalicylic acid, antiplatelet agent, anticoagulant, fibrinolytic agent, non-steroidal anti-inflammatory drug (NSAID), selective serotonin reuptake inhibitor (SSRI), or selective serotonin-norepinephrine reuptake inhibitor (SNRI)
- •Subjects who donated whole blood within 60 days or blood components within 30 days, or received blood transfusion within 30 days prior to the first administration day
- •Subjects who participated and have been exposed to an investigational product in other clinical study within 180 days prior to the first administration day
- •Subjects who consistently consumed alcohol (alcohol 21 units/week [1 unit = 10 g of pure alcohol]) within 2 weeks of the first administration day
- •Subjects who consumed grapefruit or grapefruit juice within 2 weeks of the first administration day
- •Pregnant or breastfeeding women
- •Subjects judged unsuitable to participate in the clinical study by investigators due to other reasons, including the results of laboratory tests
研究组 & 干预措施
Edoxaban and Grapefruit Juice
Experimental
- Period 1: Single dose of edoxaban 60 mg administered alone
- Period 2: Single dose of edoxaban 60 mg coadministered with grapefruit juice 3 times daily for 3 days
干预措施: Edoxaban 60 MG [Lixiana] (Drug)
Edoxaban and Grapefruit Juice
Experimental
- Period 1: Single dose of edoxaban 60 mg administered alone
- Period 2: Single dose of edoxaban 60 mg coadministered with grapefruit juice 3 times daily for 3 days
干预措施: Edoxaban 60 MG [Lixiana] + Grapefruit Juice (Other)
结局指标
主要结局
AUCinf
时间窗: 24 hours post-dose
Area under the concentration-time curve from time of administration extrapolated to infinity
Cmax
时间窗: 24 hours post-dose
maximum concentration
aPTT
时间窗: 24 hours post-dose
activated partial thromboplastin time
TGA
时间窗: 24 hours post-dose
Thrombin generation assay
PT
时间窗: 24 hours post-dose
prothrombin time
次要结局
未报告次要终点
研究者
Hyewon Chung
Assistant Professor
Korea University Guro Hospital
研究点 (1)
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