A phase I tolerance and safety study of Sailuotong capsule

Objective: To observe the tolerance and safety of healthy subjects to Sailuotong capsule,and to recommend the safe dosage for phase Ⅱ clinical trail.Methods: Thirty healthy volunteers attended the single dose trial.They received 7 different doses(60,120,180,240,300,420,540 mg) randomly.A single-blind,randomized,placebo controlled trial was adopted in continuous medication trial.The subjects in continuous medication trail was divided into low-dose group(180 mg) and high-dose group(300 mg).12 volunteers in each group received Sailuotong capsule or placebo randomly.Results: Significant changes of vital signs were not observed in all subjects of single dose trial.In continuous medication trial,there was no significant difference in incidence of adverse event between the treatment group and control group.The main adverse events included stomach discomfort,urticaria,pain in local skin,diarrhea,skin itch,thirst,abdominal distention,heart burn,dizziness and nausea.Conclusion: Sailuotong capsule is tolerated well and safe in healthy volunteers.The maximal safe dosage recommended for phase Ⅱ clinical trial was 540 mg every day.