[Translation] Fasting and postprandial, single center, randomized, open, single administration, two preparations, two cycles, crossover bioequivalence study of olmesartan medoxomil and amlodipine tablets in Chinese healthy subjects
主要目的:
观察空腹与餐后状态下分别单次口服受试制剂奥美沙坦酯氨氯地平片T[规格:每片含奥美沙坦酯20mg和苯磺酸氨氯地平5mg,郑州韩都药业集团有限公司生产]与参比制剂奥美沙坦酯氨氯地平片R[规格:每片含奥美沙坦酯20mg和苯磺酸氨氯地平5mg,第一三共制药(上海)有限公司生产]在中国成年健康受试者体内的药代动力学特征,评估空腹与餐后状态下分别口服两种制剂之间的生物等效性及个体内变异度。
次要目的:
观察空腹与餐后状态下单次口服受试制剂和参比制剂,在中国成年健康受试者中的安全性。
[Translation] main purpose:
Observe the test preparation olmesartan medoxomil and amlodipine tablets T [Specifications: Each tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine besylate, Zhengzhou Handu Pharmaceutical Group Co., Ltd. Produced by the company] and the reference preparation Olmesartan Medoxomil Amlodipine Tablets R [specification: each tablet contains 20 mg of Olmesartan Medoxomil and 5 mg of Amlodipine Besylate, produced by Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd.] in China Pharmacokinetic characteristics in adult healthy subjects, to evaluate the bioequivalence and intra-individual variability between the two preparations administered orally in the fasting and fed states.
Secondary purpose:
To observe the safety of a single oral administration of the test preparation and the reference preparation in Chinese adult healthy subjects under fasting and postprandial states.