[Translation] A randomized, open-label, two-formulation, single-dose, two-cycle, two-sequence bioequivalence study of cefixime capsules in healthy volunteers in the fasting and fed states
观察中国健康受试者在空腹/餐后状态下单次口服受试制剂头孢克肟胶囊(规格:100mg;生产企业:天津医药集团津康制药有限公司)和参比制剂头孢克肟胶囊(商品名:セフスパン®カプセル100mg;规格:100mg;生产企业(或持证商):長生堂製薬株式会社)后的药代动力学特征,评价空腹/餐后状态下两种制剂的生物等效性和安全性。
[Translation] Observe the single oral administration of the test preparation Cefixime Capsules (specification: 100mg; manufacturer: Tianjin Pharmaceutical Group Jinkang Pharmaceutical Co., Ltd.) and the reference preparation Cefixime Capsules (commercial product) to Chinese healthy subjects in the fasting/postprandial state. Name: Pharmacokinetic characteristics of SEFEX® カプセル 100mg; Specification: 100mg; Manufacturer (or license holder): Choseido Seiko Co., Ltd.), and evaluate the bioequivalence of the two preparations in the fasting/postprandial state and security.