[Translation] A single-center, randomized, open-label, fasting and postprandial single-dose, two-drug, two-sequence, two-period crossover bioequivalence study of olmesartan medoxomil and amlodipine tablets in Chinese adult healthy subjects .
主要研究目的:
考察单次单剂量口服(空腹/餐后)受试制剂奥美沙坦酯氨氯地平片【规格:每片含奥美沙坦酯20mg和苯磺酸氨氯地平5mg(以氨氯地平计),山西鑫煜制药股份有限公司生产】与参比制剂奥美沙坦酯氨氯地平片【商品名:思卫卡®,规格:每片含奥美沙坦酯20mg和苯磺酸氨氯地平5mg(以氨氯地平计),第一三共制药(上海)有限公司生产】,在中国健康人体的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性,为该药的申报及临床用药提供参考依据。
次要研究目的:
评价空腹、餐后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 research purposes:
Investigate a single single-dose oral (fasting/after meal) test preparation olmesartan medoxomil and amlodipine tablets [Specifications: Each tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine besylate (calculated as amlodipine), Produced by Shanxi Xinyu Pharmaceutical Co., Ltd.] and the reference preparation Olmesartan Medoxomil Amlodipine Tablets [trade name: Siweika®, specifications: each tablet contains 20 mg of Olmesartan Medoxomil and 5 mg of Amlodipine Besylate (with amlodipine), produced by Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd.], the relative bioavailability of healthy humans in China, the analysis of the pharmacokinetic parameters of the two preparations, and the evaluation of the bioequivalence of the two preparations. The declaration and clinical application of the drug provide a reference.
Secondary research purposes:
To evaluate the safety of a single oral administration of the test preparation and the reference preparation on an empty stomach and after a meal in Chinese adult healthy subjects.