评价格隆溴铵新斯的明注射液在全麻术后患者中用于拮抗非去极化肌肉松弛药的残留肌松作用的多中心、随机、双盲、阳性药对照的 III 期临床研究。
[Translation] A multicenter, randomized, double-blind, active-controlled Phase III clinical study was conducted to evaluate the use of glycopyrrolate-neostigmine injection in patients undergoing general anesthesia to antagonize the residual muscle relaxant effects of non-depolarizing muscle relaxants.
主要目的：以硫酸阿托品联合甲硫酸新斯的明注射液为对照，评价格隆溴铵新斯的明注射液预防新斯的明诱导心率减慢的有效性；以硫酸阿托品联合甲硫酸新斯的明注射液为对照，评价格隆溴铵新斯的明注射液拮抗肌松残留阻滞作用的有效性。
次要目的：以硫酸阿托品联合甲硫酸新斯的明注射液为对照，评价格隆溴铵新斯的明注射液的安全性。
[Translation] Primary objective: To evaluate the effectiveness of glycopyrrolate-neostigmine injection in preventing neostigmine-induced bradycardia by using atropine sulfate combined with neostigmine methylsulfate injection as a control; to evaluate the effectiveness of glycopyrrolate-neostigmine injection in antagonizing the residual blocking effect of muscle relaxant by using atropine sulfate combined with neostigmine methylsulfate injection as a control.
Secondary objective: To evaluate the safety of glycopyrrolate-neostigmine injection by using atropine sulfate combined with neostigmine methylsulfate injection as a control.
评价格隆溴铵新斯的明注射液在中国全麻术后患者中单次静脉给药后的安全性、有效性和药代动力学特征的研究
[Translation] A study to evaluate the safety, efficacy and pharmacokinetic characteristics of glycopyrrolate neostigmine injection after a single intravenous administration in Chinese patients undergoing general anesthesia after surgery
主要目的：
评价不同剂量下，格隆溴铵新斯的明注射液在中国全麻术后患者中逆转非去极化肌肉松弛药残留肌松作用时的安全性；
评价不同剂量下，格隆溴铵新斯的明注射液在中国全麻术后患者中逆转非去极化肌肉松弛药残留肌松作用时单次静脉给药的药代动力学特征。
次要目的：
评价不同剂量下，格隆溴铵新斯的明注射液在中国全麻术后患者中逆转非去极化肌肉松弛药残留肌松作用时的初步有效性。
[Translation] Primary objective:
To evaluate the safety of glycopyrrolate neostigmine injection at different doses in reversing the residual muscle relaxant effect of non-depolarizing muscle relaxants in Chinese patients after general anesthesia;
To evaluate the pharmacokinetic characteristics of glycopyrrolate neostigmine injection at different doses in reversing the residual muscle relaxant effect of non-depolarizing muscle relaxants in Chinese patients after general anesthesia.
Secondary objective:
To evaluate the preliminary effectiveness of glycopyrrolate neostigmine injection at different doses in reversing the residual muscle relaxant effect of non-depolarizing muscle relaxants in Chinese patients after general anesthesia.
/ CompletedNot Applicable 间苯三酚口崩片随机、开放、单剂量、两制剂、交叉设计在中国健康受试者中的生物等效性正式试验
[Translation] A formal bioequivalence study of phloroglucinol orally disintegrating tablets in Chinese healthy subjects using a randomized, open-label, single-dose, two-formulation, crossover design
以浙江沣华医药科技有限公司提供的间苯三酚口崩片为受试制剂；并以Teva Sante持证的间苯三酚口崩片为参比制剂，进行人体相对生物利用度和生物等效性评价。
[Translation] The orodisintegrating tablets of phloroglucinol provided by Zhejiang Fenghua Pharmaceutical Technology Co., Ltd. were used as the test preparation, and the orodisintegrating tablets of phloroglucinol certified by Teva Sante were used as the reference preparation to evaluate the relative bioavailability and bioequivalence in humans.
100 Clinical Results associated with Zhejiang Fenghua Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Zhejiang Fenghua Pharmaceutical Technology Co., Ltd.
100 Deals associated with Zhejiang Fenghua Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Zhejiang Fenghua Pharmaceutical Technology Co., Ltd.
