[Translation] A single-center, open-label, randomized, two-formulation, two-sequence, two-period, two-cycle, two-crossover human bioequivalence trial of gabapentin tablets administered orally to participants in the Chinese Health Study under fasting and postprandial conditions.
研究健康研究参与者空腹及餐后单次口服受试制剂加巴喷丁片(海南赛立克药业有限公司,规格:0.6g)与参比制剂加巴喷丁片(商品名:Neurontin®;Viatris Specialty LLC,规格:600mg)在吸收程度和速度方面是否存在差异,评价受试制剂和参比制剂在空腹及餐后状态下给药时的生物等效性,观察受试制剂和参比制剂在健康研究参与者中的安全性。
[Translation] This study investigates whether there are differences in the absorption rate and extent between the test formulation gabapentin tablets (Hainan Serik Pharmaceutical Co., Ltd., specification: 0.6g) and the reference formulation gabapentin tablets (trade name: Neurontin®; Viatris Specialty LLC, specification: 600mg) administered orally once in fasting and postprandial states in healthy study participants. It also evaluates the bioequivalence of the test and reference formulations under fasting and postprandial administration and observes the safety of the test and reference formulations in healthy study participants.