LUO Xinª²Min1,2, GUO Yaª²Quan3, GU Yi1, WANG Xiaoª²Juan1£¬WANG Rong1, BAI Juanª²Juan1, YUAN Yingª²Jin2

    1Department of Pharmacy, Stomatological College, Fourth Military Medical University, Xi¬ðan 710033, China, 2College of Chemical Engineering, Tianjin University, Tianjin 300072, China, 3Department of Pharmaceutics, Central Hospital, Tongchuan Mineral Bureau£¬ Tongchuan 727000, China

    ¡¾Abstract¡¿ AIM: To evaluate the safety of cefotaxime/sulbactam in Chinese healthy volunteers after a single intravenous infusion administration. METHODS: The trial protocol was designed according to the Good Clinical Practice (GCP). After physical examination and laboratory tests were performed, 30 healthy volunteers were divided randomly into 3 groups, including 3.0 g (cefotaxime/sulbactam£º2 g/1 g), 4.5 g (cefotaxime/sulbactam£º3 g/1.5 g) and 6.0 g (cefotaxime/sulbactam£º4 g/2 g), with 10 subjects in each group (5 male and 5 female, age range 30 to 39 years). Clinical symptoms, vital signs, routine blood tests, routine urine tests, hepatic function, renal function, blood electrolytes, and electrocardiogram were observed or examined before and after a single intravenous infusion administration of cefotaxime/sulbactam. RESULTS: After a single intravenous infusion of 3-6 g cefotaxime/sulbactam, the vital signs, clinical symptoms and laboratory tests were all in the normal range, and no adverse drug reactions were observed in every healthy volunteer. CONCLUSION: Single intravenous infusion administration of cefotaxime/sulbactam (up to 6 g) in 30 Chinese healthy volunteers is safe and tolerable. ......