[Translation] A randomized, open-label, single-dose, two-sequence, four-period, completely repeated crossover bioequivalence study of telmisartan and amlodipine tablets (80 mg/5 mg) in Chinese healthy subjects under fasting and postprandial administration conditions
主要研究目的:按有关生物等效性试验的规定,选择Boehringer Ingelheim International GmbH为持证商的替米沙坦氨氯地平片(商品名:Twynsta,规格:80mg/5mg)为参比制剂,对吉林省德商药业股份有限公司生产和持证的受试制剂替米沙坦氨氯地平片(规格:80mg/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,评估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:观察健康志愿受试者口服受试制剂替米沙坦氨氯地平片(规格:80mg/5mg)和参比制剂替米沙坦氨氯地平片(商品名:Twynsta,规格:80mg/5mg)的安全性。
[Translation] Main purpose of study: According to the provisions of relevant bioequivalence test, Telmisartan Amlodipine Tablets (trade name: Twynsta, specification: 80mg/5mg) with Boehringer Ingelheim International GmbH as the licensee was selected as the reference preparation, and the test preparation Telmisartan Amlodipine Tablets (specification: 80mg/5mg) produced and licensed by Jilin Deshang Pharmaceutical Co., Ltd. was subjected to human bioequivalence test on fasting and postprandial administration, 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 purpose of study: To observe the safety of oral administration of the test preparation Telmisartan Amlodipine Tablets (specification: 80mg/5mg) and the reference preparation Telmisartan Amlodipine Tablets (trade name: Twynsta, specification: 80mg/5mg) by healthy volunteers.