[Translation] A single-center, randomized, open-label, fasting and fed, single-dose, two-drug, three-sequence, three-period crossover bioequivalence study of telmisartan and amlodipine tablets in Chinese adult healthy subjects .
考察单次口服(空腹/餐后)受试制剂替米沙坦氨氯地平片(规格: 80mg/5mg,江苏永安制药有限公司生产,安徽佳和药业有限公司提供)与参比制剂替米沙坦氨氯地平片(Twynsta®,规格:80mg/5mg,Boehringer Ingelheim International GmbH 持证,安徽佳和药业有限公司提供)在中国成年健康受试者体内的药代动力学特征,分别评价空腹与餐后状态下口服两种制剂的生物 等效性,为该药的申报及临床用药提供参考依据。
[Translation] Investigate the single oral (fasting/after meal) test preparation Telmisartan Amlodipine Tablets (Specification: 80mg/5mg, produced by Jiangsu Yongan Pharmaceutical Co., Ltd., provided by Anhui Jiahe Pharmaceutical Co., Ltd.) and the reference preparation Telmisartan The pharmacokinetic characteristics of amlodipine sartan tablets (Twynsta®, specification: 80mg/5mg, licensed by Boehringer Ingelheim International GmbH, provided by Anhui Jiahe Pharmaceutical Co., Ltd.) in Chinese adult healthy subjects were evaluated by fasting The bioequivalence between the two preparations and oral administration in the postprandial state provides a reference for the application and clinical use of the drug.