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艾拉戈克钠片在健康受试者中空腹和餐后状态下的开放、随机、交叉生物等效性试验
[Translation] An open-label, randomized, crossover bioequivalence trial of Elagog Sodium Tablets in healthy subjects under fasting and postprandial conditions
1、 主要研究目的:研究空腹和餐后状态下单次口服受试制剂艾拉戈克钠片(规格:0.2g,四川恩威制药有限公司生产)与参比制剂艾拉戈克钠片(商品名Orilissa®,规格:0.2g;AbbVie Inc.生产)在健康受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
2、 次要研究目的:评估受试制剂艾拉戈克钠片(规格:0.2g)与参比制剂Orilissa®(规格:0.2g)在健康受试者中的安全性。
[Translation] 1. Main research purpose: To study the single oral administration of the test preparation Elagog Sodium Tablets (specification: 0.2g, produced by Sichuan Enwei Pharmaceutical Co., Ltd.) and the reference preparation Elagog Sodium Tablets ( The pharmacokinetics of Orilissa® (trade name: 0.2g; produced by AbbVie Inc.) in healthy subjects was evaluated to evaluate the bioequivalence of the two oral preparations in the fasting and postprandial states.
2. Secondary research purpose: To evaluate the safety of the test preparation Elagog sodium tablets (specification: 0.2g) and the reference preparation Orilissa® (specification: 0.2g) in healthy subjects.
丹龙片治疗乳腺增生病(气滞血瘀证)多中心 随机 双盲 安慰剂对照Ⅲ期临床试验
[Translation] Multicenter randomized, double-blind, placebo-controlled phase III clinical trial of Danlong Tablets in the treatment of mammary gland hyperplasia (Qi stagnation and blood stasis syndrome)
进一步评价丹龙片治疗乳腺增生病(气滞血瘀证)的临床有效性及安全性
[Translation] To further evaluate the clinical efficacy and safety of Danlong Tablets in the treatment of mammary gland hyperplasia (Qi stagnation and blood stasis syndrome)
100 Clinical Results associated with Sichuan Enwei Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Sichuan Enwei Pharmaceutical Co., Ltd.
100 Deals associated with Sichuan Enwei Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Sichuan Enwei Pharmaceutical Co., Ltd.