[Translation] A bioequivalence study of hydrocortisone tablets in healthy participants under fasting and postprandial conditions, using an open-label, randomized, single-dose, two-formulation, two-sequence, two-period crossover design.
研究空腹和餐后状态下单次口服受试制剂(氢化可的松片,规格10mg,大玮(安徽)药业有限公司持证)和参比制剂(氢化可的松片,规格10mg,PHARMACIA AND UPJOHN CO持证)在健康试验参与者体内的药代动力学特征,比较受试制剂与参比制剂的生物等效性,并研究药物在健康试验参与者体内的安全性。
[Translation] This study investigated the pharmacokinetic characteristics of a single oral dose of the test formulation (hydrocortisone tablets, 10 mg, certified by Dawei (Anhui) Pharmaceutical Co., Ltd.) and the reference formulation (hydrocortisone tablets, 10 mg, certified by PHARMACIA AND UPJOHN CO.) in healthy trial participants under fasting and postprandial conditions, compared the bioequivalence of the test and reference formulations, and studied the safety of the drugs in healthy trial participants.