Evaluation of Pharmacokinetic parameters of Cibenzoline after Administration of a Single Oral Dose in Healthy Volunteers

概要

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In this study, a pharmacokinetic model of cibenzoline in healthy volunteers was examined in order to design a pharrnacokinetic model for establishing a relevant dosage regimen for patients with arrhythmias. Seven healthy volunteers between 25 and 43 years of age participated in the study. Each volunteer received two 100-mg capsules of cibenzoline with 150mL of water at 9 am after overnight fasting. Blood samples were collected before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, and 24 hours after the oral dose. The serum cibenzoline concentrations were measured by a high perforrnance liquid chromatography (HPLC) with ultraviolet detection at 230nm. The pharmacokinetics of cibenzoline in the healthy volunteers could be described using the one-compartment model (ke=0. 283hr^<-1>, Vd=0. 249L/kg, ka=0.953hr^<-1>) in healthy volunteers. The means of t_<max> and C_<max> were 1.32 hr and 631ng/mL, respectively. A significant correlation was found between the predicted concentrations using our obtained one-compartment pharmacokinetic parameters and those observed in patients treated with cibenzoline for one month or longer. These results indicate that the one-compartment model is therefore useful for studying the pharmacokinetics of cibenzoline after oral administration.
日本医療薬学会の論文
2001-08-10