[Translation] An open-label, balanced, randomized, single oral-dose, two-agent, two-sequence, two-cycle, double-crossover fasting bioequivalence study of olmesartan, hydrochlorothiazide, and amlodipine tablets in healthy subjects.
1. 旨在评估健康成年受试者空腹接受氨氯地平/氢氯噻嗪/奥美沙坦酯10 mg/25 mg/40 mg片剂(中国广东省广州市玻思韬控释药业有限公司,邮编510530)和TRIBENZOR(含氨氯地平、氢氯噻嗪、奥美沙坦酯)10 mg/25 mg/40 mg片剂(美国新泽西州帕西帕尼市第一三共株式会社美国子公司,邮编07054;由德国第一三共株式会社欧洲子公司生产)的单次口服给药的生物等效性。
2. 监测空腹临床状况、不良事件和实验室检查,并评估相对安全性和对氨氯地平/氢氯噻嗪/奥美沙坦制剂的耐受性。
[Translation] 1. To evaluate healthy adult subjects receiving amlodipine/hydrochlorothiazide/olmesartan medoxomil 10 mg/25 mg/40 mg tablets on an empty stomach (Guangzhou Bositao Controlled-Release Pharmaceutical Co., Ltd., Guangdong Province, China, 510530 ) and TRIBENZOR (containing amlodipine, hydrochlorothiazide, olmesartan medoxomil) 10 mg/25 mg/40 mg tablets (Daiichi Sankyo Co., Ltd., Parsippany, NJ 07054, USA; by Germany Bioequivalence of single oral administration of Daiichi Sankyo Co., Ltd. European subsidiary).
2. Monitor fasting clinical status, adverse events, and laboratory tests, and assess relative safety and tolerability to amlodipine/hydrochlorothiazide/olmesartan formulations.