比索洛尔氨氯地平片在中国健康受试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 bisoprolol and amlodipine tablets in Chinese healthy volunteers after meal administration
主要研究目的：按有关生物等效性试验的规定，选择Merck Kft为持证商的比索洛尔氨氯地平片（商品名：康忻安，规格：富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)5mg）为参比制剂，对烟台鲁银药业有限公司生产、济南良福精合医药科技有限公司提供的受试制剂比索洛尔氨氯地平片（规格：富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)5mg)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。
次要研究目的：观察健康受试者口服受试制剂比索洛尔氨氯地平片（规格：富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)5mg)和参比制剂比索洛尔氨氯地平片（商品名：康忻安，规格：富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)5mg）的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, Bisoprolol Amlodipine Tablets (trade name: Kangxinan, specification: 5mg bisoprolol fumarate and 5mg amlodipine besylate (calculated as amlodipine)) with Merck Kft as the licensee were selected as the reference preparation, and the test preparation Bisoprolol Amlodipine Tablets (specification: 5mg bisoprolol fumarate and 5mg amlodipine besylate (calculated as amlodipine)) produced by Yantai Luyin Pharmaceutical Co., Ltd. and provided by Jinan Liangfu Jinghe Pharmaceutical Technology Co., Ltd. were subjected to postprandial human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under postprandial administration conditions.
Secondary study objective: To observe the safety of oral administration of the test preparation bisoprolol amlodipine tablets (specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) and the reference preparation bisoprolol amlodipine tablets (trade name: Kangxin'an, specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) to healthy subjects.
比索洛尔氨氯地平片在中国健康受试者中空腹和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 bisoprolol and amlodipine tablets in Chinese healthy volunteers under fasting and fed conditions
主要研究目的：按有关生物等效性试验的规定，选择Merck Kft为持证商的比索洛尔氨氯地平片（商品名：康忻安，规格：富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)5mg）为参比制剂，对烟台鲁银药业有限公司生产、济南良福精合医药科技有限公司提供的受试制剂比索洛尔氨氯地平片（规格：富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)5mg)进行空腹和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，评价两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的：观察健康受试者口服受试制剂比索洛尔氨氯地平片（规格：富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)5mg)和参比制剂比索洛尔氨氯地平片（商品名：康忻安，规格：富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)5mg）的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, Bisoprolol Amlodipine Tablets (trade name: Kangxinan, specification: 5mg bisoprolol fumarate and 5mg amlodipine besylate (calculated as amlodipine)) with Merck Kft as the licensee was selected as the reference preparation, and the test preparation Bisoprolol Amlodipine Tablets (specification: 5mg bisoprolol fumarate and 5mg amlodipine besylate (calculated as amlodipine)) produced by Yantai Luyin Pharmaceutical Co., Ltd. and provided by Jinan Liangfu Jinghe Pharmaceutical Technology Co., Ltd. were subjected to fasting and postprandial human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary study objective: To observe the safety of oral administration of the test preparation bisoprolol amlodipine tablets (specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) and the reference preparation bisoprolol amlodipine tablets (trade name: Kangxinan, specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) to healthy subjects.
100 Clinical Results associated with Jinan Liangfu Jinghe Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Jinan Liangfu Jinghe Pharmaceutical Technology Co., Ltd.
100 Deals associated with Jinan Liangfu Jinghe Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Jinan Liangfu Jinghe Pharmaceutical Technology Co., Ltd.
