YANG Guo-ping1��XIONG Xuan2��YUAN Hong1*��TAN Hong-yi1��OUYANG Dong-sheng3��HUANG Zhi-jun1��TAN Zhi-rong3��LIU Dong-bo4��LIU Chang1
1. Third Xiangya Hospital of Central South University��Changsha 410013��China��2. Sichuan Academy of Medical Science & Sichuan Provincial People��s Hospital��Chengdu 610072��China��3. Institute of Clinical Pharmacology of Central South University��Changsha 410008��China��4. Hunan Agriculture University��Changsha 410128��China
Abstract��
OBJECTIVE To evaluate the potential pharmacokinetic interaction occurring during the concomitant administration of pitavastatin and the oil of grape seeds in healthy volunteers. METHODS A randomized,cross-over study was performed with two phases separated by a washout period of two weeks. Eight healthy volunteers were given either pitavastatin aone or the combination of pitavastatin and the oil of grape seeds capsules for 7 d. The plasma concentrations of pitavastatin were measured by HPLC-MS/MS. RESULTS The parameters of the coadministration of the oil of grape seeds and pitavastatin,and pitavastatin alone were as follows:AUC (52.9��66.26) and (135.556��76.13) ��g��h��L-1,��max(33.51��15.12) and (33.11��21.32) ��g��L-1,tmax(0.69��0.26) and (0.88��0.44) h,t1/2 (15.76��12.12) and (11.75��6.89) h,CL (15.4��1.76) and (17.11��5.03) L��h-1.CONCLUSION In healthy volunteers,the oil of grape seeds had no significant effect on the pharmacokinetics of pitavastatin after multiple administration,except t1/2.
.Effect of the Oil of Grape Seeds on the Pharmacokinetics of Pitavastatin in Healthy Volunteers [J] Chinese Pharmaceutical Journal, 2009,V44(14): 1089-1092
��
[1]
SUNGHA P��HYUN-JAE K��SE-JOONG R��et al. A randomized��open-label study to evaluate the efficacy and safety of pitavastatin compared with simvastatin in korean patientswith hyper cholesterolemia[J]. Clin Ther��2005��27(7)��1074-1082.
[2]
GUO D L��ZHANG G X��SUN H Y. A new superstatin���� pitavastatin calcium[J].Qilu Pharmaceutical Affairs(��³ҩ��)��2004��23 (1)��61-62.
[3]
XIAO J��YUAN H��YANG G P��et al. A summary on 48 cases of hyperlipidemia treated by seed of romanet grape oil soft capsule [J].Hunan Journal of Traditional Chinese Medicine (������ҽ��־)��2006��22(2)��5-6.
[4]
HE Y H��XU M. A antilipemic agent����pitavastatin[J].World Clinical Drugs�������ٴ�ҩ���2005��26(3)��187-187.
[5]
WANG J��TOKORO T��MATSUI K��et al. Effect of OATP1B1 (SLCO1B1) variant alleles on the pharmacokinetics of pitavastatinin healthy volunteers [J]. Life Sci��������ѧ����2005��76��2257-2268.
[6]
CHUNG J Y��CHO J Y��YU K S��et al. Effect of OATP1B1 (SLCO1B1) variant alleles on the pharmacokinetics of pitavastatin in healthy volunteers[J].Clin Pharmacol Ther ��2005��78��342-350.