Abstract��
OBJECTIVE To study the pharmacokinetics and relative bioavailabilty of nimodipine sustained-release tablets and to evaluate the bioequivalence. METHODS A single dose and multiple oral doses of nimodipine sustained-release tablets (the test and the reference) were given to 18 healthy volunteers in a randomized,crossover study. The nimodipine concentration in plasma was determined by High Performance Liquid Chromatography (HPLC). RESULTS The main pharmacokinetic parameters for a single oral dose of 60 mg test and reference preparation were calculated as the follows:t1/2 (2.70��0.48) and (2.85��0.81) h;��max(31.00��9.13) and (32.13��10.00) ��g��L-1;tmax(2.97��0.88) and (2.89��0.76 ) h. AUC0-t (177.64��42.43) and (186.41��49.37) ��g��h��L-1,AUC0-��(190.20��45.22) and (204.34��54.46) ��g��h��L-1.The relative bioavailability of the test was (99.18��25.08) %. The pharmacokinetic parameters of multiple doses study were as follows:the mean steady state ��ss max (42.37��6.34) and (45.66��6.88) ��g��L-1;��ss min(13.37��3.37) and (13.51��2.55) ��g��L-1;DFss(118.57��21.09) and (127.22��27.54)%. The relative bioavailability of the test wa(s97.11��12.25)%. CONCLUSION No statistical differences were observed between these two preparations,the results showed that the two preparations were bioequivalent.
2009, Vol. 44 
