[Translation] A randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover bioequivalence study of spironolactone tablets in healthy Chinese subjects under fasting and postprandial conditions.
主要目的:以江苏长江药业有限公司提供的螺内酯片为受试制剂,按生物等效性研究的有关规定,与原研厂Piramal Healthcare UK Limited (Pfizer Inc.)生产的螺内酯片(商品名:Aldactone)在健康成年受试者中比较吸收速度及吸收程度的差异,考察两制剂的人体生物等效性。 次要目的:观察受试制剂螺内酯片和参比制剂Aldactone在健康成年受试者中的安全性。
[Translation] Primary objective: To compare the absorption rate and extent of spironolactone tablets (test formulation) provided by Jiangsu Changjiang Pharmaceutical Co., Ltd. with those of the original manufacturer, Piramal Healthcare UK Limited (Pfizer Inc.) (trade name: Aldactone), in healthy adult subjects, in accordance with relevant regulations for bioequivalence studies, and to examine the human bioequivalence of the two formulations. Secondary objective: To observe the safety of the test formulation spironolactone tablets and the reference formulation Aldactone in healthy adult subjects.