[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of pregabalin capsules in healthy subjects under fasting/fed administration conditions
主要目的:考察中国健康受试者在空腹/餐后条件下单剂量口服成都恒瑞制药有限公司生产的普瑞巴林胶囊与 Pfizer Manufacturing Deutschland GmbH,Betriebsstatte Freiburg 生产的(持证商:Upjohn EESV )普瑞巴林胶囊后的体内药代动力学特征,评价两制剂的生物等效性。
次要目的:评价单剂量口服普瑞巴林胶囊受试制剂及参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To investigate the in vivo pharmacokinetic characteristics of pregabalin capsules produced by Chengdu Hengrui Pharmaceutical Co., Ltd. and pregabalin capsules produced by Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg (licensed by Upjohn EESV) in healthy Chinese subjects after a single oral dose under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of the test and reference preparations of pregabalin capsules after a single oral dose in healthy Chinese subjects.