Study on the Drug Interaction Between Buagafuran and Voriconazole (NCT07457203) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study on the Drug Interaction Between Buagafuran and Voriconazole
China18 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;