Pharmacokinetics and bioavailability of sustained release capsules of nicardipine hydrochloride in healthy volunteers

AIM To compared the pharmacokinetics and relative bioavailability between sustained release capsules of domestic and imported nicardipine hydrochloride METHODS Plasma levels of nicardipine was measured by GCECD following a single and multiple oral doses of two capsules(domestic and imported preparations) given to 12 healthy volunteers in a randomized 2way crossover studyRESULTS The concentration versus time curves became bimodal when two sustained release capsules of nicardipine hydrochloride were given before mealsAfter a single oral dose the main pharmacokinetic parameters were C max1 (142±82) and C max2 (169±58) μg·L -1 at (079±045) and (508±079) h, T 1/2Ke (549±253) h,AUC 0～24 (979±248) μg·h·L -1 for domestic capsules Following multiple dosing mean steady state parameter values were C max (367±61) μg·L -1 , C min (73±16) μg·L -1 ,C av (189±32)μg·L -1 , FI (156±026), AUC 0～36 (3414±485) μg·h·L -1 for domestic capsules Relative bioavailabilities of domestic capsules were 975%±193% and 982%±165% compared with imported capsules after a single and multiple oral administration of the two preparations, respectively CONCLUSION The statistic test showed that the pharmacokinetic parameters were no significantly different between the two kind of preparations and bioequivalence of both domestic and imported nicardipine capsules were proved