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.
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);
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;
Single group
Buagafuran
DrugBuagafuran, oral administration 30mg, signal dose in the morning of day1 and day5
Voriconazole
DrugVoriconazole tablets, oral administration 400 mg BID on day3, and Voriconazole tablets oral administration 200 mg BID from day4 to day6.
Pharmacokinetics of Buagafuran（ Cmax）
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)
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)
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.
incidence of adverse events
To assess the safety of combination of Buagafuran and voriconazole in healthy participants.
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This trial is not recruiting at the moment. You can still explore other options:
