[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of acyclovir tablets (0.4g) administered orally to healthy participants after a fasting single oral dose.
主要研究目的:研究空腹状态下单次口服受试制剂阿昔洛韦片(规格:0.4g,浙江亚太药业股份有限公司生产)与参比制剂阿昔洛韦片(Zovirax®)(规格:400mg,グラクソ·スミスクライン株式会社生产, Glaxo Smithkline K.K.持证)在健康成年试验参与者体内的药代动力学,评价空腹状态口服两种制剂的生物等效性。
次要研究目的:研究空腹状态下,单次口服受试制剂阿昔洛韦片和参比制剂阿昔洛韦片在健康成年试验参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetics of a single oral dose of the test formulation acyclovir tablets (0.4g, manufactured by Zhejiang Asia-Pacific Pharmaceutical Co., Ltd.) and the reference formulation acyclovir tablets (Zovirax®) (400mg, manufactured by Glaxo Smithkline Co., Ltd., licensed by Glaxo Smithkline K.K.) in healthy adult participants under fasting conditions, and to evaluate the bioequivalence of the two formulations under fasting conditions.
Secondary objective: To investigate the safety of a single oral dose of the test formulation acyclovir tablets and the reference formulation acyclovir tablets in healthy adult participants under fasting conditions.