/ CompletedNot Applicable 普瑞巴林口崩片(150 mg)在健康受试者中的单次给药、随机、开放、两周期、双交叉、空腹及餐后状态下的生物等效性研究
[Translation] A single-dose, randomized, open-label, two-period, double-crossover bioequivalence study of pregabalin orodisintegrating tablets (150 mg) in healthy subjects under fasting and fed conditions
主要研究目的:以Pfizer Japan Inc.持证的普瑞巴林口崩片(150 mg)为参比制剂,以广州帝奇医药技术有限公司研发的普瑞巴林口崩片(150 mg)为受试制剂,通过单中心、随机、开放、单次给药、两周期、双交叉临床研究来评价两种制剂在空腹及餐后状态下的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use the pregabalin orodisintegrating tablets (150 mg) licensed by Pfizer Japan Inc. as the reference preparation and the pregabalin orodisintegrating tablets (150 mg) developed by Guangzhou Diqi Pharmaceutical Technology Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations in the fasting and postprandial state through a single-center, randomized, open, single-dose, two-cycle, double-crossover clinical study.
Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.
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