KCT0008365尚未招募Unknown
An exploratory clinical trial to evaluate the effect of Banhabaekchulcheonmatang and Hwangryeonhaedoktang on the pharmacokinetics and pharmacodynamics of aspirin in healthy adults
Hanyang University Seoul Hospital0 个研究点目标入组 14 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
- 14
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) BMI of 18 to 32 kg/m2 (inclusive)
- •3) Agree to use medically acceptable methods of contraception by participant, and not to donate sperm or oocyte
- •4) Voluntarily decided to participate in the study and provided written consent to comply with the protocol
排除标准
- •1) Current or history of a clinically significant cardiovascular, respiratory, hepatic, renal, hemato-oncological, gastrointestinal, endocrine, immunological, dermatological, or neuropsychiatric disease
- •2) History of hypersensitivity reactions that are clinically significant or hypersensitivity reactions to the components or constituents of the investigational product
- •3) Who has clinically significant hemorrhage or an increased risk of hemorrhage due to the following conditions
- •A. Stomach ulcers within 6 months
- •B. Malignant tumor with a high risk of bleeding
- •C. Brain or spinal cord injury or surgery
- •D. Opthalmic surgery within 6 months
- •E. 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. Biopsy or major trauma within 6 months
- •I. Bacterial endocarditis
- •J. Esophagitis, Gastritis, or Gastroesophageal reflux within 6 months
- •4) Individuals with a history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •5) Individuals whose eGFR calculated by the CKD-EPI formula is 80mL/min or less at screening
- •6) AST or ALT levels that are more than double the upper limit of normal range, or total bilirubin levels that have increased by more than 1.5 times the upper limit of normal range at screening
- •7) Platelet count <150,000 /mm3 at screening
- •8) Individuals who have taken the follwoing 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 Banhabaekchulcheonmatang or Hwangryeonhaedoktang
- •9) Donated whole blood within 60 days or blood components within 30 days, or received blood transfusion within 30 days prior to the date of the first dose of this study
- •10) Participated in another clinical study and have been exposed to an investigational product within 180 days prior to the date of the first dose of this study
- •11) Excessive intake of alcohol (alcohol > 21 units/week [1 unit = 10 mL of pure alcohol]) within 2 weeks of the first dose of this study
- •12) Pregnant or breastfeeding women
- •13) Positive result in serology tests including hepatitis B tests, human immunodeficiency virus (HIV) tests, hepatitis C tests
- •14) The investigator has determined that the subject is not suitable to participate in the clinical study due to other reasons, including the results of laboratory tests.
研究者
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