Phase I clinical tolerability trial of(S)-ornidazole tablets

AIM: To evaluate the tolerability of(S)-ornidazole in healthy volunteers. METHODS: It is a randomized,blinded,placebo-controlled single-center clinical study.Fowrty-eight healthy volunteers enrolled the study.Thirty-eight healthy volunteers were randomly divided into four groups to attend single-dose tolerability trial(250,500,1000,1500 mg,respectively).Ten healthy volunteers entered multi-dose tolerability trial for 7 days [1000 mg(S)-ornidazole,Qd].Two healthy volunteers of each group were given placebo.Vital signs,electrocardiogram and serum biochemical indicators were observed before and after(S)-ornidazole administration and adverse effects were recorded.RESULTS:In the study,there were no abnormal findings in vital signs,electrocardiogram and serum biochemical indicators.20 healthy volunteers experienced mild adverse effects of dizziness,fatigue,drowsiness nausea and so on.CONCLUSION:(S)-ornidazole tablet is safe for healthy volunteers at daily dose of 250 to 1000 mg.