[Translation] A comparative pharmacokinetic study of 102D-6 dry suspension and mabaloxavir tablets in healthy subjects under fasting conditions in a single-center, randomized, open-label, single-dose, two-period, double-crossover manner
主要目的:
在空腹状态下,比较单次口服34mg卡文迪许(泰州)药业有限公司研制的102D-6干混悬剂(规格:40mg/袋)与40mg Roche Pharma (Schweiz) AG持证的玛巴洛沙韦片(速福达®/Xofluza®,40mg/片)在健康成年受试者中活性代谢产物巴洛沙韦的药代动力学特征,并评估两者相对生物利用度。
次要目的:
1)评估健康成年受试者空腹状态下单次口服34mg 102D-6干混悬剂(规格:40mg/袋)的安全性;
2)评估健康成年受试者空腹状态下单次口服34mg 102D-6干混悬剂与40mg 玛巴洛沙韦片的生物等效性。
[Translation] Primary Objective:
To compare the pharmacokinetic profile of the active metabolite baloxavir after a single oral dose of 34 mg of 102D-6 dry suspension (40 mg/bag) developed by Cavendish (Taizhou) Pharmaceutical Co., Ltd. and 40 mg of Roche Pharma (Schweiz) AG's licensed mabaloxavir tablets (Xofluza®, 40 mg/tablet) in healthy adults under fasting conditions, and to assess their relative bioavailability.
Secondary Objectives:
1) To evaluate the safety of a single oral dose of 34 mg of 102D-6 dry suspension (40 mg/bag) in healthy adults under fasting conditions;
2) To evaluate the bioequivalence of a single oral dose of 34 mg of 102D-6 dry suspension and 40 mg of mabaloxavir tablets in healthy adults under fasting conditions.