[Translation] A randomized, open-label, fasting, single-dose, three-cycle, three-crossover bioequivalence pilot trial of recombinant secretagogue injection in healthy subjects
以北京博康健基因科技有限公司生产的重组促胰岛素分泌素注射液(0.25mg/ml,2.4ml/支)为受试制剂,以北京博康健基因科技有限公司生产的注射用重组促胰岛素分泌素(10μg/支)为参比制剂1,以Baxter Pharmaceutical Solutions LLC生产(持证商:AstraZeneca AB)的艾塞那肽注射液(0.25mg/ml,2.4ml/支)为参比制剂2,评估健康受试者单次皮下注射受试制剂和参比制剂时的相对生物利用度,初步评估受试制剂和参比制剂生物等效的可能性,为本药生物等效正式试验设计提供参考依据。
[Translation] The recombinant secretagogue injection (0.25mg/ml, 2.4ml/piece) produced by Beijing Bokangjian Gene Technology Co., Ltd. was used as the test preparation, and the recombinant secretagogue for injection produced by Beijing Bokangjian Gene Technology Co., Ltd. was used as the test preparation. (10μg/vial) is the reference preparation 1, and exenatide injection (0.25mg/ml, 2.4ml/vial) produced by Baxter Pharmaceutical Solutions LLC (licensee: AstraZeneca AB) is the reference preparation 2, evaluation The relative bioavailability of the test preparation and the reference preparation in a single subcutaneous injection to healthy subjects, to preliminarily evaluate the possibility of bioequivalence between the test preparation and the reference preparation, and to provide a reference for the design of the bioequivalence formal trial of this drug .