Study on safety and tolerability of single-dose of penehyclidine hydrochloride in healthy volunteers

Objective: To observe the tolerability and safety of penehyclidine hydrochloride in healthy subjects and recommend the safe dosage for multiple dose medication and phase II clinical trial. Methods: Thirty-six healthy volunteers were enrolled in the single dose trial. They received one of the eight dosagees( 0. 1,0. 2,0. 3,0. 4,0. 6,0. 8,1. 0,1. 2 mg) randomly. The safety was evaluated based on clinical symptoms,vital signs,laboratory tests,electrocardiogram and adverse events. Results: Thirty-two healthy volunteers completed the tolerability test. The post-treatment heart rates were significantly decreased than baseline( P 0. 05),but not dose-dependently. Incidence of blurred vision was more than 50%. Sinus bradycardia and sinus arrhythmia were observed in the subjects. First degree atrioventricular heart-block and frequent atrial premature beats were found in several subjects by electrocardiogram. Significant changes in other vital signs and laboratory tests or serious adverse events were not observed in none of the subjects during the trial. Conclusion: Penehyclidine hydrochloride tablets are well tolerated and safe in healthy volunteers. The maximal tolerance dosage is 0. 8 mg daily. The dose regimen of 0. 6mg·d- 1is recommended for multiple dose medication trials.