/ Active, not recruitingNot Applicable 维生素K1注射液在中国健康参与者中静脉注射给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of vitamin K1 injection in healthy Chinese participants under intravenous administration conditions
按有关生物等效性试验的规定，选择Cheplapharm Arzneimittel GmbH为持证商的维生素K1注射液（商品名：Konakion MM；规格：1mL:10mg）为参比制剂，对江苏安必生制药有限公司生产并提供的受试制剂维生素K1注射液（规格：1mL:10mg）进行静脉注射给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在静脉注射给药条件下的生物等效性。
[Translation] In accordance with the relevant provisions of bioequivalence tests, vitamin K1 injection (trade name: Konakion MM; specification: 1mL: 10mg) produced by Cheplapharm Arzneimittel GmbH was selected as the reference preparation, and the test preparation vitamin K1 injection (specification: 1mL: 10mg) produced and provided by Jiangsu Anbisheng Pharmaceutical Co., Ltd. was subjected to a human bioequivalence test for intravenous administration. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see whether they were within an acceptable range, and the bioequivalence of the two preparations under intravenous administration conditions was evaluated.
/ Active, not recruitingNot Applicable 维生素K1注射液在中国健康参与者中餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验。
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of vitamin K1 injection in healthy Chinese participants after meal administration.
按有关生物等效性试验的规定，选择Cheplapharm Arzneimittel GmbH为持证商的维生素K1注射液（商品名：Konakion MM；规格：1mL:10mg）为参比制剂，对江苏安必生制药有限公司生产并提供的受试制剂维生素K1注射液（规格：1mL:10mg）进行餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在餐后给药条件下的生物等效性。
[Translation] In accordance with the relevant provisions of bioequivalence tests, vitamin K1 injection (trade name: Konakion MM; specification: 1mL: 10mg) produced by Cheplapharm Arzneimittel GmbH was selected as the reference preparation, and the test preparation vitamin K1 injection (specification: 1mL: 10mg) produced and provided by Jiangsu Anbisheng Pharmaceutical Co., Ltd. was subjected to a postprandial human bioequivalence test to compare whether the absorption rate and degree of the drug in the test preparation were within an acceptable range with those of the reference preparation, and to evaluate the bioequivalence of the two preparations under postprandial administration conditions.
/ CompletedNot Applicable 维生素K1注射液（1mL:10mg）在中国健康参与者中空腹给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of vitamin K1 injection (1 mL: 10 mg) in Chinese healthy participants under fasting conditions
按有关生物等效性试验的规定，选择Cheplapharm Arzneimittel GmbH为持证商的维生素K1注射液（商品名：Konakion MM；规格：1mL:10mg）为参比制剂，对江苏安必生制药有限公司生产并提供的受试制剂维生素K1注射液（规格：1mL:10mg）进行空腹给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹给药条件下的生物等效性。
[Translation] In accordance with the relevant provisions of bioequivalence tests, vitamin K1 injection (trade name: Konakion MM; specification: 1mL: 10mg) produced by Cheplapharm Arzneimittel GmbH was selected as the reference preparation, and the test preparation vitamin K1 injection (specification: 1mL: 10mg) produced and provided by Jiangsu Anbisheng Pharmaceutical Co., Ltd. was subjected to a human bioequivalence test on an empty stomach. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see whether they were within an acceptable range, and the bioequivalence of the two preparations under conditions of fasting administration was evaluated.
100 Clinical Results associated with Jiangsu Anbisheng Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Jiangsu Anbisheng Pharmaceutical Co., Ltd.
100 Deals associated with Jiangsu Anbisheng Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Jiangsu Anbisheng Pharmaceutical Co., Ltd.
