Comparation of pharmacokinetics of midazolam tablet in Chinese Hui,Korean and Han healthy subjects / 中国药理学通报

ABSTRACT

Aim To study the pharmacokinetics of midazolam tablet after a single oral dose in Hui,Koreanand Han healthy volunteers.Methods Ten Hui, ten Han and nine Korean healthy volunteers were involved in the study. Each subject received a single dose of 15 mg midazolam tablets. The plasma concentration was determined by HPLC. The pharmacokinetic parameters were calculated by DAS2.0 software and compared by one-way analysis of variance or KrusKal-Wallis rank test for PK parameters of different nationalities.Results There were statistically significant differences between Hui,Korean and Han nationality for PK parameters C_(max),MRT_(0～12 h) and T_(max)(P＜0.05).The ranges of interindividual variation in the different ethnic groups and the same ethnic group were large.There were not satisfactory differences between young males and females for all pharmacokinetic parameters(P＞0.05).Followimg oral administration, doublepeaks in midazolam blood concentration-time profiles were observed in more than half of subjects.Conclusion There are large interindividual variation and statistically significant difference in pharmacokinetics of midazolam tablet between Chinese Hui, Korean and Han.These observations suggest the dosage of midazolam should be adjusted in clinical practice.