[Translation] A randomized, open-label, single-dose, two-sequence, two-formulation, two-period, double-crossover design bioequivalence study of healthy adult subjects taking a single oral dose of olmesartan medoxomil and amlodipine tablets on an empty stomach and after a meal
主要目的 研究空腹和餐后状态下单次口服受试制剂奥美沙坦酯氨氯地平片(规格:奥美沙坦酯20mg/苯磺酸氨氯地平5mg(以氨氯地平计),宁波大红鹰药业股份有限公司生产)与参比制剂奥美沙坦酯氨氯地平片(规格:奥美沙坦酯20mg/苯磺酸氨氯地平5mg(以氨氯地平计),第一三共制药(上海)有限公司生产)在健康成年受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。 次要目的 评价健康成年受试者在空腹和餐后状态下,单次口服奥美沙坦酯氨氯地平片受试制剂和参比制剂后的安全性。
[Translation] The main purpose is to study the test preparation Olmesartan Medoxomil Amlodipine Tablets (specification: Olmesartan Medoxomil 20mg/ Amlodipine Besylate 5mg (calculated as amlodipine)) under fasting and postprandial status, Ningbo Dahongying Pharmaceutical Co., Ltd.) and the reference preparation olmesartan medoxomil amlodipine tablets (specification: olmesartan medoxomil 20mg/amlodipine besylate 5mg (calculated as amlodipine), Daiichi Sankyo Pharmaceutical (Shanghai ) Co., Ltd.) Pharmacokinetics in healthy adult subjects to evaluate the bioequivalence of the two preparations orally in the fasting and postprandial state. Secondary purpose To evaluate the safety of healthy adult subjects after a single oral administration of olmesartan medoxomil and amlodipine tablets test preparation and reference preparation in fasting and postprandial state.