[Translation] A single-center, randomized, open-label, single-dose, two-dose, three-period crossover bioequivalence study to evaluate the efficacy of allopurinol tablets in healthy Chinese adult subjects under fasting and fed conditions
主要研究目的:
考察单次口服(空腹/餐后)受试制剂别嘌醇片和参比制剂别嘌醇片,在中国成年健康受试者体内的药代动力学特征,评估空腹与餐后条件下分别口服两种制剂的生物等效性。
次要研究目的:
评价空腹/餐后条件下单次口服1片受试制剂和参比制剂在中国成年健康受试者中的安全性。
[Translation] Main study objectives:
To investigate the pharmacokinetic characteristics of the test preparation Allopurinol Tablets and the reference preparation Allopurinol Tablets in healthy adult Chinese subjects after a single oral administration (fasting/postprandial), and to evaluate the bioequivalence of the two preparations after oral administration under fasting and postprandial conditions.
Secondary study objectives:
To evaluate the safety of a single oral administration of one tablet of the test preparation and the reference preparation in healthy adult Chinese subjects under fasting/postprandial conditions.