[Translation] A randomized, open-label, two-sequence, two-cycle, double-crossover design of a bioequivalence trial of a single oral dose of pyrazinamide tablets in healthy Chinese subjects
主要目的:研究空腹和餐后单次口服吡嗪酰胺片受试制剂(0.5g,杭州苏泊尔南洋药业有限公司)与吡嗪酰胺片参比制剂(500 mg,持证商:Par Pharmaceutical.)后吡嗪酰胺在中国健康受试者体内的药代动力学行为,评价空腹和餐后口服两种制剂的生物等效性。
次要目的:评价中国健康受试者空腹和餐后单次口服吡嗪酰胺片受试制剂和参比制剂后的安全性。
[Translation] Main purpose: To study the test preparation of pyrazinamide tablets (0.5g, Hangzhou Supor Nanyang Pharmaceutical Co., Ltd.) and the reference preparation of pyrazinamide tablets (500 mg, license holder: Par Pharmaceutical.) Post-Pharmacokinetic Behavior of Pyrazinamide in Chinese Healthy Subjects, Evaluation of Bioequivalence of Two Formulations Oral Fasting and Meal.
Secondary objective: To evaluate the safety of test and reference preparations after a single oral administration of pyrazinamide tablets on an empty stomach and after meals in healthy Chinese subjects.