KCT0009530尚未招募Unknown
A clinical trial to evaluate the effect of Bojungikgitang, Ijintang, or Cheongsanggyeontongtang on the pharmacokinetics and pharmacodynamics of edoxaban in healthy adults
Koera University Guro Hospital0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 50(Year)（—）
- 性别
- All
入选标准
- •1) Adults aged 19 to 50 years of age (inclusive) at the time of screening
- •2) Subjects with BMI of 18 to 32 kg/m2 (inclusive)
- •3) Subjects who agree to use medically acceptable methods of contraception and not to donate sperm or oocyte
- •4) Subjects who voluntarily decided to participate in the study and provided written consent to comply with the protocol
排除标准
- •1) Subjects with current or history of clinically significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, or neuropsychiatric disease
- •2) Subjects with current or history of clinically significant hypersensitivity reactions or hypersensitivity reactions to the components or constituents of the investigational product
- •3) 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
- •4) Subjects with a history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •5) Subjects whose eGFR calculated by the CKD-EPI formula is 80mL/min or less at screening
- •6) 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
- •7) Subjects whose coagulation test (aPTT, PT) exceeds the normal range at screening
- •8) 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)
- •C. Herbal medicine, Korean traditional medicine, or supplements that contains the ingredients of Bojungikgitang, Ijintang, or Cheongsanggyeontongtang
- •9) 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
- •10) Subjects who participated and have been exposed to an investigational product in other clinical study within 180 days prior to the first administration day
- •11) Subjects who consistently consumed alcohol (alcohol > 21 units/week [1 unit = 10 mL of pure alcohol]) within 2 weeks of the first administration day
- •12) Pregnant or breastfeeding women
- •13) Subjects judged unsuitable to participate in the clinical study by investigators due to other reasons, including the results of laboratory tests
研究者
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