Phase I human tolerability trial of aildenafil citrate tablet

Objective: To assess the tolerability and safety of aildenafil citrate tablet in healthy Chinese male volunteers.Methods: Twenty-eight healthy Chinese male subjects were recruited to the single dose study.They were divided into 30,60,90 and 120 mg dose step with 30 mg as the first dose step;safety and tolerability findings at the previous dose level were the basis for the decision to proceed to the next higher dose level.Thirty-six healthy Chinese male subjects were enrolled to the multiple dose study,and the escalated dose level were 30,45 and 60 mg·d-1,once daily for continuous 3 days.The safety was assessed based on clinical symptoms and adverse events.Results: In the single dose study,the adverse events judged by the investigator to be related to aildenafil citrate tablet were abnormal vision(35.7%),flushing(21.4%),headache or dizziness(17.9%).In the multiple dose study,the adverse events related to aildenafil citrate tablet were flushing(7.4%),headache or dizziness(7.4%).There were no serious adverse events;all adverse events were mild in severity and resolved without any treatment.There were no clinically significant changes in vital signs,clinical laboratory tests and ophthalmological examination.Conclusion: Aildenafil citrate tablet is safe and well-tolerated in Chinese male healthy subjects after single doses of 30~120 mg and multiple doses of 30~60 mg,qd for 3 days.