[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of single oral administration of prednisolone tablets in healthy subjects on an empty stomach or after a meal
主要研究目的: 研究空腹和餐后状态下单次口服受试制剂泼尼松龙片(规格:5mg,天津信谊津津药业有限公司生产)与参比制剂泼尼松龙片(Millipred®,规格:5mg, Watson Pharma Private Limited生产, WATSON LABORATORIES INC持证)在健康成年受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的: 空腹和餐后状态下,研究单次口服受试制剂泼尼松龙片和参比制剂泼尼松龙片(Millipred®)在健康成年受试者中的安全性。
[Translation] Main study objectives: To study the pharmacokinetics of the test preparation prednisolone tablets (specification: 5 mg, produced by Tianjin Xinyi Jinjin Pharmaceutical Co., Ltd.) and the reference preparation prednisolone tablets (Millipred®, specification: 5 mg, produced by Watson Pharma Private Limited, licensed by WATSON LABORATORIES INC) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary study objectives: To study the safety of the test preparation prednisolone tablets and the reference preparation prednisolone tablets (Millipred®) in healthy adult subjects after a single oral administration in the fasting and fed state.