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[Translation] Bioequivalence study of azithromycin capsules in human body
主要目的:
以Pliva Croatia Ltd.生产的阿奇霉素胶囊(Sumamed®,0.25g/粒)为参比制剂,以武汉双龙药业有限公司生产的阿奇霉素胶囊(0.25g/粒)为受试制剂,评价两种制剂的生物等效性及相对生物利用度。
次要目的:
观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective:
Using azithromycin capsules (Sumamed®, 0.25 g/capsule) produced by Pliva Croatia Ltd. as the reference preparation and azithromycin capsules (0.25 g/capsule) produced by Wuhan Shuanglong Pharmaceutical Co., Ltd. as the test preparation, the bioequivalence and relative bioavailability of the two preparations were evaluated.
Secondary objective:
Observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.
柴连感冒颗粒治疗急性上呼吸道感染(风热证)的有效性及安全性随机双盲安慰剂平行对照剂量探索多中心IIa期临床
[Translation] Efficacy and safety of Chailian Ganmao granules in the treatment of acute upper respiratory tract infection (wind-heat syndrome): a randomized double-blind placebo-controlled parallel dose-exploring multicenter phase IIa clinical trial
(1) 初步评价柴连感冒颗粒治疗急性上呼吸道感染(风热证) 的有效性。 (2)探索柴连感冒颗粒治疗急性上呼吸道感染(风热证) 的合理剂量, 为Ⅱb 期临床研 究提供依据。 (3)观察柴连感冒颗粒治疗急性上呼吸道感染(风热证) 的安全性。
[Translation] (1) To preliminarily evaluate the effectiveness of Chailian Ganmao Granules in treating acute upper respiratory tract infection (wind-heat syndrome). (2) To explore the reasonable dosage of Chailian Ganmao Granules in treating acute upper respiratory tract infection (wind-heat syndrome) and provide a basis for Phase IIb clinical study. (3) To observe the safety of Chailian Ganmao Granules in treating acute upper respiratory tract infection (wind-heat syndrome).
金柴抗感胶囊治疗普通感冒(风热证)评价其有效性和安全性的随机双盲、剂量探索、多中心Ⅱ期临床研究
[Translation] A randomized, double-blind, dose-finding, multicenter phase II clinical study to evaluate the efficacy and safety of Jinchai Kanggan Capsule in the treatment of common cold (wind-heat syndrome)
1.评价金柴抗感胶囊改善普通感冒症状、缩短普通感冒热程的作用,并进行剂量探索;
2.探索金柴抗感胶囊对于普通感冒的即时退热作用;
3.探索金柴抗感胶囊改善感冒风热证的疗效;
4.观察金柴抗感胶囊的安全性及不良反应。
[Translation] 1. To evaluate the effect of Jinchai Kanggan Capsule in improving the symptoms of common cold and shortening the fever course of common cold, and to explore the dosage;
2. To explore the immediate antipyretic effect of Jinchai Kanggan Capsule on common cold;
3. To explore the efficacy of Jinchai Kanggan Capsule in improving wind-heat syndrome of cold;
4. To observe the safety and adverse reactions of Jinchai Kanggan Capsule.
100 Clinical Results associated with Wuhan Shuanglong Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Wuhan Shuanglong Pharmaceutical Co., Ltd.
100 Deals associated with Wuhan Shuanglong Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Wuhan Shuanglong Pharmaceutical Co., Ltd.