[Translation] A randomized, open-label, single-dose, fasting and fed, two-formulation, two-sequence, two-period crossover bioequivalence study of penicillin V potassium tablets in healthy Chinese adult subjects
主要目的:观察单次口服0.25g(空腹/餐后)受试制剂青霉素V钾片(规格:0.25g/片,山西好医生药业有限公司生产)与参比制剂青霉素V钾片(规格:0.25g/片,Sandoz GmbH 生产)在中国成年健康受试者体内的吸收速度及吸收程度,初步评估空腹与餐后状态下分别口服两种制剂的人体生物等效性。
次要目的:观察受试制剂和参比制剂单次口服0.25g(空腹/餐后)在中国成年健康受试者中的安全性。
[Translation] Primary objective: To observe the absorption rate and extent of a single oral dose of 0.25g (fasting/after meals) of the test preparation Penicillin V Potassium Tablets (Specification: 0.25g/tablet, produced by Shanxi Good Doctor Pharmaceutical Co., Ltd.) and the reference preparation Penicillin V Potassium Tablets (Specification: 0.25g/tablet, produced by Sandoz GmbH) in healthy adult Chinese subjects, and to preliminarily evaluate the bioequivalence of the two preparations in humans when taken orally in fasting and after meals.
Secondary objective: To observe the safety of a single oral dose of 0.25g (fasting/after meals) of the test preparation and the reference preparation in healthy adult Chinese subjects.