/ CompletedNot Applicable 迈华替尼片在健康受试者中随机、开放、两制剂、两周期、双交叉、单次给药空腹状态下的生物等效性试验
[Translation] A randomized, open-label, two-dose, two-cycle, double-crossover, single-dose bioequivalence study of Maihuatinib tablets in healthy subjects under fasting conditions
研究空腹状态下单次口服受试制剂T1迈华替尼片1片(规格:80mg/片,杭州中美华东制药有限公司生产)与受试制剂T2迈华替尼片4片(规格:20mg/片,杭州中美华东制药有限公司生产)在健康成年受试者体内的药代动力学,评价空腹状态口服两种制剂的生物等效性。
[Translation] The pharmacokinetics of a single oral dose of the test formulation T1 Maihuatinib tablet (specification: 80 mg/tablet, produced by Hangzhou Sino-US Huadong Pharmaceutical Co., Ltd.) and the test formulation T2 Maihuatinib tablets (specification: 20 mg/tablet, produced by Hangzhou Sino-US Huadong Pharmaceutical Co., Ltd.) in healthy adult subjects were studied in the fasting state, and the bioequivalence of the two oral preparations in the fasting state was evaluated.
迈华替尼治疗EGFR罕见突变(G719X,L861Q,S768I)的 晚期非小细胞肺癌II期开放、单臂、多中心临床试验
[Translation] Phase II open, single-arm, multicenter clinical trial of Maihuatinib in the treatment of advanced non-small cell lung cancer with rare EGFR mutations (G719X, L861Q, S768I)
1) 主要目的: 评估迈华替尼治疗EGFR罕见突变的晚期非小细胞肺癌的有效性。 2) 次要目的: 评估迈华替尼治疗EGFR罕见突变的晚期非小细胞肺癌的安全性。
[Translation] 1) Primary objective: To evaluate the efficacy of mehuatinib in the treatment of advanced non-small cell lung cancer with rare EGFR mutations. 2) Secondary objective: To evaluate the safety of mehuatinib in the treatment of advanced non-small cell lung cancer with rare EGFR mutations.
迈华替尼60mg或80mg一线治疗EGFR敏感突变的晚期非小细胞肺癌的多中心、随机、开放、Ⅱ期临床试验
[Translation] A multicenter, randomized, open-label, phase II clinical trial of mahuatinib 60 mg or 80 mg as first-line treatment for advanced non-small cell lung cancer with EGFR-sensitive mutations
主要目的: 评估迈华替尼60mg或80mg一线治疗EGFR敏感突变的晚期非小细胞肺癌的有效性。 次要目的: 评估迈华替尼60mg或80mg一线治疗EGFR敏感突变的晚期非小细胞肺癌的安全性。
[Translation] Primary objective: To evaluate the efficacy of mehuatinib 60mg or 80mg as first-line treatment for advanced non-small cell lung cancer with EGFR sensitive mutations. Secondary objective: To evaluate the safety of mehuatinib 60mg or 80mg as first-line treatment for advanced non-small cell lung cancer with EGFR sensitive mutations.
100 Clinical Results associated with Suzhou Maitai Bio-Technology Co., Ltd.
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100 Deals associated with Suzhou Maitai Bio-Technology Co., Ltd.
100 Translational Medicine associated with Suzhou Maitai Bio-Technology Co., Ltd.