Bioequivalence of ambroxol hydrochloride capsules in healthy volunteers

OBJECTIVE:To study the relative bioequivalence between ambroxol capsules(test drug)and its standard tablets(reference drug)and pharmacokinetics in 12 healthy male volunteers.METHODS:A dose of 90 mg of domestic of imported ambroxol(test and reference preparation)was given according to a randonized 2 way cross over disign, blood samples were withdrawn up to 24 hours post administation,and plasma concentration of ambroxol was determined by high performance liquid chromatography(HPLC).RESULTS:The concentration time curves of two preparations fitted to a one compartment model.The peak plasma levels( C max )of ambroxol test drug and reference drug were(385.5±98.3)and(378.9±90.3) μg·L -1 respectively,the peak time( T max )were(1.5±0.3) h and (1.6±0.4) h, AUC 0 t were(2421.2±761.3)and (2485.9±803.9) μg·h·L -1 ,respectively. The relative bioavailability of the test drug was(97.9±6.7)%.CONCLUSIONS:The pharmacokinetics and relative bioavailability data obtained in the study furnished definite proof of bioequivalence of both domestic ambroxol capsules and imported ambroxol tablets. [