[Translation] A clinical study evaluating the interaction of oral BR005-036C tablets with rifampin, itraconazole, or midazolam in healthy trial participants.
主要目的:1.在健康成年试验参与者中评估多次口服CYP3A4诱导剂利福平胶囊对BR005-036C片药代动力学特征的影响;2.在健康成年试验参与者中评估多次口服CYP3A4/P-gp抑制剂伊曲康唑胶囊对BR005-036C片PK特征的影响; 3. 在健康成年试验参与者中评估多次口服BR005-036C片对CYP3A底物咪达唑仑PK特征的影响。 次要目的:在健康成年试验参与者中评估BR005-036C片分别与利福平、伊曲康唑、咪达唑仑合并用药的安全性和耐受性
[Translation] Primary Objectives: 1. To evaluate the effect of multiple oral administrations of the CYP3A4 inducer rifampin capsules on the pharmacokinetic characteristics of BR005-036C tablets in healthy adult participants; 2. To evaluate the effect of multiple oral administrations of the CYP3A4/P-gp inhibitor itraconazole capsules on the pharmacokinetic characteristics of BR005-036C tablets in healthy adult participants; 3. To evaluate the effect of multiple oral administrations of BR005-036C tablets on the pharmacokinetic characteristics of the CYP3A substrate midazolam in healthy adult participants. Secondary Objectives: To evaluate the safety and tolerability of BR005-036C tablets in combination with rifampin, itraconazole, and midazolam in healthy adult participants.