Abstract:

Objective To evaluate the tolerability of healthy subjects to faropenem sodium injection. Methods Thirty-one healthy volunteers were randomly divided into single-dose group (n=24; 200, 400, 800, 1 000 and 1 200 mg faropenem sodium by intravenous drip) and multiple-dose group (n=7; 400mg faropenem sodium, Bid, 7 d). Vital signs, electrocardiogram and serum biochemical indicators were observed before and after faropenem sodium administration, and adverse effects were recorded. Results There were no abnormal findings in vital signs, electrocardiogram and serum biochemical indicators 1, 8 and 24 h after single-dose administration. One subject experienced mild drug-unrelated adverse effects of diarrhea and bellyache, and recovered 1 d later. There were no abnormal findings in vital signs, electrocardiogram and serum biochemical indicators 4 and 8 d after multiple-dose administration, and no adverse event occurred. Conclusion Faropenem sodium for injection is safe at a dose of 200 mg to 1 200 mg as single-dose administration or at a dose of 400 mg as multiple-dose administration.

Key words: faropenem sodium for injection, single-dose, multiple-dose, tolerability trial