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/ Active, not recruitingPhase 1 评估中国健康成年受试者空腹单次口服13C-102D-6,与102D-6干混悬剂以及与玛巴洛沙韦片的生物等效性和相对生物利用度研究
[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.
一项在健康受试者中评估102D-6干混悬剂安全性、耐受性的随机、双盲、安慰剂对照的I期临床研究
[Translation] A randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety and tolerability of 102D-6 dry suspension in healthy subjects
主要目的:
1.评价在健康受试者中单次口服102D-6干混悬剂后的安全性、耐受性;
2.评价食物对102D-6干混悬剂药代动力学的影响。
次要目的:
1.评价在健康受试者中单次口服102D-6干混悬剂后的药代动力学特征;
2.评价健康受试者在餐后状态下口服102D-6干混悬剂的安全性。
[Translation] Main objectives:
1. To evaluate the safety and tolerability of 102D-6 dry suspension after a single oral administration in healthy subjects;
2. To evaluate the effect of food on the pharmacokinetics of 102D-6 dry suspension.
Secondary objectives:
1. To evaluate the pharmacokinetic characteristics of 102D-6 dry suspension after a single oral administration in healthy subjects;
2. To evaluate the safety of 102D-6 dry suspension after oral administration in healthy subjects in the postprandial state.
/ CompletedNot Applicable [Translation] Bioequivalence study of metoclopramide tablets (10 mg) in healthy volunteers
主要目的:
本研究以卡文迪许(泰州)药业有限公司持有,江苏悦兴药业有限公司生产的甲氧氯普胺片(规格:10 mg)为受试制剂,按生物等效性研究有关规定,以ANI PHARMACEUTICALS INC持有的甲氧氯普胺片(规格:10 mg,商品名:REGLAN®)为参比制剂,评估受试制剂和参比制剂在空腹条件下给药后的生物等效性。
次要目的:
观察受试制剂甲氧氯普胺片和参比制剂甲氧氯普胺片(REGLAN®)在健康受试者中的安全性。
[Translation] Main purpose:
This study used metoclopramide tablets (specification: 10 mg) owned by Cavendish (Taizhou) Pharmaceutical Co., Ltd. and produced by Jiangsu Yuexing Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, metoclopramide tablets (specification: 10 mg, trade name: REGLAN®) owned by ANI PHARMACEUTICALS INC were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting conditions.
Secondary purpose:
Observe the safety of the test preparation metoclopramide tablets and the reference preparation metoclopramide tablets (REGLAN®) in healthy subjects.
100 Clinical Results associated with Nanjing Cavendish Bio-engineering Technology Co., Ltd.
0 Patents (Medical) associated with Nanjing Cavendish Bio-engineering Technology Co., Ltd.
100 Deals associated with Nanjing Cavendish Bio-engineering Technology Co., Ltd.
100 Translational Medicine associated with Nanjing Cavendish Bio-engineering Technology Co., Ltd.