[Translation] A bioequivalence study of methylprednisolone tablets in healthy participants under fasting conditions, using a single-dose, randomized, open-label, two-period, two-sequence, two-crossover design.
主要研究目的:研究空腹状态下单次口服受试制剂甲泼尼龙片(规格:4mg,天津信谊津津药业有限公司生产)与参比制剂甲泼尼龙片(美卓乐®,规格:4mg, Pfizer Italia S.r.l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:空腹状态下,研究单次口服受试制剂甲泼尼龙片和参比制剂甲泼尼龙片(美卓乐®)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 methylprednisolone tablets (4 mg, manufactured by Tianjin Xinyi Jinjin Pharmaceutical Co., Ltd.) and the reference formulation methylprednisolone tablets (Medrol®, 4 mg, certified by Pfizer Italia S.r.l.) 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 methylprednisolone tablets and the reference formulation methylprednisolone tablets (Medrol®) in healthy adult participants under fasting conditions.