Bioequivalence of zaleplon tablets in healthy volunteers

OBJECTIVE To evaluate the bioequivalence of zaleplon tablets in healthy volunteers.METHODS The drug concentrations in plasma were determined by high performance liquid chromatography RP(HPLC RP) method following a single oral dose of 15 mg of tested zaleplon tablets and reference zaleplon capsules given respectively to 20 healthy male volunteers in an open randomized crossover design. The pharmacokinetic parameters and relative bioavailability were calculated on the basis of compartment models by using 3p97 program to evaluate the bioequivalence of the two dosage forms.RESULTS The concentration time curves of the two dosage forms were fitted to one compartment model with oral absorption. AUC 0-8 of the tested drug and reference drug were ( 123.6 ± 25.6 ) μg·L -1 ·h and( 128.6 ± 29.0 ) μg·L -1 ·h, C max were ( 55.9 ± 16.2 ) μg·L -1 and ( 61.6 ± 16.7 ) μg·L -1 , T peak were ( 1.0 ± 0.3 ) h and ( 0.99 ± 0.22 ) h, T 1/2ke were ( 1.00 ± 0.29 ) h and ( 0.93 ± 0.13 ) h, respectively.These main pharmacokinetic parameters obtained showed no statistically significant difference between two products ( P 0.05 ). CONCLUSIONS Both preparations are bioequivalent.The relative bioavailability of the tested tablet to reference capsule is ( 97.7 ± 14.5 )%.