[Translation] A single-center, randomized, open-label, single-dose, two-preparation, two-cycle, double-crossover fasting and postprandial absorption kinetics trial of allopurinol tablets
研究健康受试者在空腹及餐后条件下,单次口服由广州新济药业科技有限公司提供、澳美制药(海南)有限公司生产的别嘌醇片(受试制剂T,规格:300mg)与相同条件下单次口服由Aspen Pharma Trading Limited.持证的别嘌醇片(参比制剂R,商品名:Zyloric®,规格:300mg)的药动学特征,比较两制剂间药动学参数AUC 和Cmax 的差异,初步评估受试制剂与参比制剂吸收动力学的一致性。
[Translation] Healthy subjects were studied to take a single oral dose of allopurinol tablets (test preparation T, specification: 300 mg) provided by Guangzhou Xinji Pharmaceutical Technology Co., Ltd. and produced by Aomei Pharmaceutical (Hainan) Co., Ltd. under fasting and postprandial conditions. ) and the pharmacokinetic characteristics of allopurinol tablets (reference preparation R, trade name: Zyloric®, specification: 300mg) licensed by Aspen Pharma Trading Limited. under the same conditions. Compare the pharmacokinetics between the two preparations. The difference in parameters AUC and Cmax provides a preliminary assessment of the consistency of the absorption kinetics of the test preparation and the reference preparation.