[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence trial evaluating the test formulation cefoperazone hydrochloride granules (50 mg) and the reference formulation cefoperazone hydrochloride granules (50 mg) in healthy adult participants under fasting and postprandial conditions.
主要研究目的:评估空腹和餐后状态下单次口服受试制剂盐酸头孢卡品酯颗粒(规格:50 mg,山东淄博新达制药有限公司生产)与参比制剂盐酸头孢卡品酯颗粒(规格:50 mg,Shionogi Pharma Co., Ltd. Kanegasaki Plant生产)在健康成年参与者体内的药代动力学,评价空腹和餐后状态下口服两种制剂的生物等效性。
次要研究目的:评估受试制剂盐酸头孢卡品酯颗粒(规格:50 mg)和参比制剂盐酸头孢卡品酯颗粒(规格:50 mg)在健康成年参与者中的安全性。
[Translation] Primary objective: To evaluate the pharmacokinetics of a single oral dose of the test formulation cefcaptin hydrochloride granules (50 mg, manufactured by Zibo Xinda Pharmaceutical Co., Ltd., Shandong) and the reference formulation cefcaptin hydrochloride granules (50 mg, manufactured by Shionogi Pharma Co., Ltd. Kanegasaki Plant) in healthy adult participants under fasting and postprandial conditions, and to assess the bioequivalence of the two formulations under fasting and postprandial conditions.
Secondary objective: To evaluate the safety of the test formulation cefcaptin hydrochloride granules (50 mg) and the reference formulation cefcaptin hydrochloride granules (50 mg) in healthy adult participants.