12
Participants
Start Date
December 14, 2015
Primary Completion Date
January 13, 2016
Study Completion Date
January 13, 2016
Banapenem
Twelve healthy adult volunteers, half male and female, are enrolled and randomly assigned to three groups, B1, B2, and B3. The subjects in three groups receive three doses, 250 mg, 500 mg and 1000 mg. Each group of subjects receive single-dose test drug at different dosages in each period. The subjects are divided into two groups, C1 and C2, 12 subjects in each group, half males and half females. 250 mg group is performed first. After completion of observation and confirming that the drug can be safely tolerated, study on 500 mg group is then performed
Sihuan Pharmaceutical Holdings Group Ltd.
INDUSTRY