[Translation] Evaluation of the bioequivalence and relative bioavailability of 13C-102D-6, 102D-6 dry suspension and mabaloxavir tablets after a single oral fasting dose in healthy Chinese adults
主要目的: 评估和比较空腹条件下单次同时口服13C-102D-6干混悬剂20mg和玛巴洛沙韦片20mg或102D-6干混悬剂20mg在健康受试者中的药代动力学特征,评价13C-102D-6干混悬剂与玛巴洛沙韦片的相对生物利用度、13C-102D-6干混悬剂与102D-6干混悬剂的生物等效性,并通过13C-102D-6干混悬剂桥接102D-6干混悬剂较玛巴洛沙韦片的相对生物利用度。 次要目的: 1. 评估中国健康成年受试者单次口服13C-102D-6干混悬剂与102D-6干混悬剂的安全性与耐受性,并与玛巴洛沙韦片进行比较;
2. 为后续研究102D-6的剂量设计以及与玛巴洛沙韦片的生物等效性、药效和安全性桥接提供数据支持;
3. 比较102D-6干混悬剂与玛巴洛沙韦片的血浆代谢产物。
[Translation] Main objective: To evaluate and compare the pharmacokinetic characteristics of a single simultaneous oral administration of 20 mg 13C-102D-6 dry suspension and 20 mg mabaloxavir tablets or 20 mg 102D-6 dry suspension in healthy subjects under fasting conditions, to evaluate the relative bioavailability of 13C-102D-6 dry suspension and mabaloxavir tablets, the bioequivalence of 13C-102D-6 dry suspension and 102D-6 dry suspension, and to bridge the relative bioavailability of 102D-6 dry suspension to mabaloxavir tablets through 13C-102D-6 dry suspension. Secondary objectives: 1. To evaluate the safety and tolerability of a single oral dose of 13C-102D-6 dry suspension and 102D-6 dry suspension in healthy Chinese adult subjects, and compare them with mabaloxavir tablets;
2. To provide data support for the subsequent study of the dose design of 102D-6 and the bioequivalence, efficacy and safety bridge with mabaloxavir tablets;
3. To compare the plasma metabolites of 102D-6 dry suspension and mabaloxavir tablets.