[Translation] A single-center, open-label, sequential administration clinical study to evaluate the drug-drug interactions between frutinib succinate capsules, itraconazole capsules, and rifampicin capsules in healthy adult subjects
主要研究目的:评价伊曲康唑胶囊、利福平胶囊分别对中国健康受试者口服丁二酸复瑞替尼胶囊后丁二酸复瑞替尼主要药代动力学参数的影响;
次要研究目的:1)评价伊曲康唑胶囊、利福平胶囊分别对中国健康受试者口服丁二酸复瑞替尼胶囊后丁二酸复瑞替尼其他药代动力学参数的影响;2)评价中国健康受试者单剂量口服丁二酸复瑞替尼胶囊及分别与伊曲康唑胶囊、利福平胶囊联合用药的安全性;
探索性目的:定性分析中国健康受试者单剂量口服丁二酸复瑞替尼胶囊及分别与伊曲康唑胶囊、利福平胶囊联合用药后粪便中的代谢物。
[Translation] Main study objectives: To evaluate the effects of itraconazole capsules and rifampicin capsules on the main pharmacokinetic parameters of succinate succinate succinate succinate capsules in healthy Chinese subjects;
Secondary study objectives: 1) To evaluate the effects of itraconazole capsules and rifampicin capsules on other pharmacokinetic parameters of succinate succinate succinate capsules in healthy Chinese subjects; 2) To evaluate the safety of single-dose oral administration of succinate succinate succinate capsules and combined administration with itraconazole capsules and rifampicin capsules in healthy Chinese subjects;
Exploratory objectives: To qualitatively analyze the metabolites in feces of healthy Chinese subjects after single-dose oral administration of succinate succinate succinate capsules and combined administration with itraconazole capsules and rifampicin capsules.