[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the test formulation of pregabalin capsules (strength: 150 mg) and the reference formulation (Lyrica®) (strength: 150 mg) in healthy adult subjects in the fasting and fed state
研究空腹和餐后状态下单次口服受试制剂普瑞巴林胶囊(规格:150 mg,湖南赛隆药业有限公司生产)与参比制剂普瑞巴林胶囊(乐瑞卡®,规格:150 mg;Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg生产)在健康受试者体内的药代动力学特征,评价空腹和餐后状态口服两种制剂的生物等效性,研究其在健康受试者中的安全性。
[Translation] The pharmacokinetic characteristics of the test preparation pregabalin capsules (specification: 150 mg, produced by Hunan Sailon Pharmaceutical Co., Ltd.) and the reference preparation pregabalin capsules (Lyrica®, specification: 150 mg; produced by Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg) were studied in healthy subjects after a single oral administration in the fasting and fed state, the bioequivalence of the two preparations in the fasting and fed state was evaluated, and their safety in healthy subjects was studied.