[Translation] A randomized, open-label, single-dose, fasting/postprandial, two-prescription, two-sequence, two-period crossover bioequivalence study of pyrazinamide tablets in healthy adult Chinese subjects
主要目的:考察单次口服0.5g(空腹/餐后)受试制剂吡嗪酰胺片(规格:0.5g/片,江苏四环生物制药有限公司生产)与参比制剂Pyrazinamide Tablets(规格:500mg/片,DAVA PHARMACEUTICALS INC生产)在中国成年健康受试者体内的药代动力学特征,分别评价空腹与餐后状态下口服两种制剂的生物等效性。 次要目的:评价受试制剂和参比制剂单次口服0.5g(空腹/餐后)在中国成年健康受试者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic characteristics of a single oral dose of 0.5 g (fasting/after meal) of the test preparation Pyrazinamide Tablets (Specification: 0.5 g/tablet, produced by Jiangsu Sihuan Biopharmaceutical Co., Ltd.) and the reference preparation Pyrazinamide Tablets (Specification: 500 mg/tablet, produced by DAVA PHARMACEUTICALS INC) in healthy adult Chinese subjects, and to evaluate the bioequivalence of the two preparations in fasting and after meal conditions. Secondary objective: To evaluate the safety of a single oral dose of 0.5 g (fasting/after meal) of the test preparation and the reference preparation in healthy adult Chinese subjects.