Clinical Study on the Drug Interaction Between Buagafuran Capsules and Voriconazole Tablets in Chinese Adult Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of Buagafuran（ Cmax）
研究概览
简要总结
This study is a non-randomized, open label trial aimed at evaluating the drug interaction between Buagafuran capsules and voriconazole tablets in Chinese adult healthy participants.The research period is 7 days in total.
详细描述
This study is a single center, non-randomized, open label trial aimed at evaluating the drug interaction between Buagafuran capsules and voriconazole tablets in Chinese adult healthy participants.
The number of participants in this study is 18, and it is planned to enroll 4-6 participants for the trial first. After completing the day7 safety check, the remaining participants will enter the group.
Participants are required to take a single dose of 30 mg Buagafuran on the morning of day1 and day5. Voriconazole tablets (400 mg BID) orally on day3, and voriconazole tablets (200 mg BID) orally from day4 to day6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Voluntarily sign an informed consent form before the start of activities related to this experiment and be able to understand the procedures of this experiment Willing to strictly adhere to the clinical trial protocol and complete this trial in accordance with the method;
- •Participants (including partners) are willing to have no fertility plans from screening to within 6 months after the last administration of the investigational drug, and voluntarily adopt highly effective contraceptive measures (specific contraceptive measures can be found in Appendix 1);
- •On the day of signing the informed consent form, the age range is 18 to 45 years old (including both ends), and both males and females are eligible;
- •Male participants weighing no less than 50 kg and female participants weighing no less than 45 kg; Body Mass Index (BMI)19-28 kg/m2 (including both ends), body mass index (BMI)=weight (kg)/height 2 (m2);
- •Creatinine clearance rate (calculated using the Cockcroft Gault formula, see Appendix 2) ≥ 80 mL/min.
排除标准
- •Screening period physical examination, vital sign examination, 12 lead electrocardiogram, clinical laboratory examination (blood routine Abnormal and clinically significant factors such as blood biochemistry, urine routine, coagulation function, etc. have been identified by researchers;
- •Clinical findings indicate the presence of the following diseases: including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, and endocrine disorders Secretory, tumor, lung, immune, psychiatric or cardiovascular diseases that the researcher deems unsuitable to participate in this study Researcher;
- •Any potential impact on the safety of the trial or drug absorption, distribution, metabolism, or excretion within the first 6 months of screening Individuals with a history of surgery or trauma, or those planning to undergo surgery during the study period;
- •History of swallowing difficulties or any gastrointestinal diseases that affect drug absorption, including frequent malignant events caused by any underlying cause Individuals with a history of heart or vomiting;
- •Individuals with a history of eye diseases (such as retinal hemorrhage, optic nerve abnormalities, etc.);
- •Individuals with previous risk factors for arrhythmia, such as congenital or acquired QTc interval prolongation, cardiomyopathy, and menstrual disorders Researchers have identified clinically significant abnormalities such as sinus bradycardia;
- •Participate in blood donation within 3 months prior to screening and donate ≥ 400 mL (excluding female menstrual bleeding), or Blood transfusion recipients;
- •Screening for use of other clinical trial drugs within the first 3 months or planned participation in other clinical trials during the study period The person;
- •Individuals with a history of drug abuse, drug dependence, drug use, or urinary drug abuse within the past 5 years prior to screening Individuals with positive screening results;
- •Individuals with a history of alcohol abuse or those who have frequently consumed alcohol within the past 6 months, i.e. those who consume ≥ 14 units of alcohol per week (1 Unit=360 mL of beer with an alcohol content of 5%, 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of alcohol 12% wine), or any alcoholic product taken on the day before the first dose, or alcohol blowing Individuals who test positive for alcohol or are unable to stop consuming alcohol during the study period;
- •Excessive smoking (≥ 5 cigarettes/day) within the first 3 months of screening, or inability to stop smoking during the trial period;
- •Those who are positive in any index screening of hepatitis B surface antigen, hepatitis C antibody, HIV antigen/antibody or syphilis antibody;
- •Used any drugs that affect liver enzymes within the previous month (or 5 times half-life, whichever is longer) before screening Active drugs (including inhibitors and inducers that affect metabolic enzymes);
- •Within 14 days prior to the first use of the investigational drug, any prescription, over-the-counter, herbal, or herbal medicine has been used Health products (excluding topical preparations that exert local effects);
- •Consuming grapefruit or products containing grapefruit, caffeine, and yellow within 48 hours prior to taking the investigational drug Foods or beverages containing purines or alcohol (including chocolate, tea, coffee, cola, etc.); Intense exercise, or Those who have other factors that affect drug absorption, distribution, metabolism, excretion, etc;
- •Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection;
- •Allergic constitution, including severe drug allergies or a history of drug allergies, known to be sensitive to experimental drugs or drugs Individuals allergic to any ingredient in the medication;
- •From the screening stage to the occurrence of acute illness or concomitant medication before the study drug;
- •Pregnant or lactating women, or women of childbearing age who test positive for pregnancy;
- •Researchers believe that there are other factors that are not suitable for participating in this experiment.
研究组 & 干预措施
Buagafuran+Voriconazole
Participants took a single dose of 30 mg of Buagafuran capsules on day1 and day5; voriconazole tablets (400 mg, BID) on day3, and voriconazole tablets (200 mg, BID) from day4 to day6.
干预措施: Buagafuran (Drug)
Buagafuran+Voriconazole
Participants took a single dose of 30 mg of Buagafuran capsules on day1 and day5; voriconazole tablets (400 mg, BID) on day3, and voriconazole tablets (200 mg, BID) from day4 to day6.
干预措施: Voriconazole (Drug)
结局指标
主要结局
Pharmacokinetics of Buagafuran（ Cmax）
时间窗: From day1 to day7
To evaluate the potential effect of multiple oral doses of Voriconazole on the single-dose PK of Buagafuran. Maximum observed concentration (Cmax).
Pharmacokinetics of Buagafuran (AUC0-inf)
时间窗: From day1 to day7
To evaluate the potential effect of multiple oral doses of Voriconazole on the single-dose PK of Buagafuran.Area under the concentration-time curve (AUC0-inf) from time zero to infinity.
Pharmacokinetics of Buagafuran (AUC0-t)
时间窗: From day1 to day7
To evaluate the potential effect of multiple oral doses of Voriconazole on the single-dose PK of Buagafuran.Area under the concentration-time curve (AUC0-t) time zero to last quantifiable concentration.
次要结局
- incidence of adverse events(From day1 to day7)