[Translation] Randomized, open, single-dose, two-dose, two-sequence, self-crossover control design, to evaluate the bioequivalence formal trial of Chinese healthy subjects after a single oral administration of spironolactone tablets in fasting state
主要目的:以苏州弘森药业股份有限公司提供的螺内酯片受试制剂,按生物等效性试验的有关规定,与Pfizer Inc.持证的螺内酯片(商品名:Aldactone®,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
[Translation] Main purpose: To compare the test preparation of spironolactone tablets provided by Suzhou Hongsen Pharmaceutical Co., Ltd. with the spironolactone tablets (trade name: Aldactone®, reference preparation) licensed by Pfizer Inc. in accordance with the relevant regulations of bioequivalence test Compare the absorption speed and absorption degree in healthy human body, and investigate the human bioequivalence of the two preparations.