Bioequivalence Study of Compound Nicotinic Acid Bilayer Sustained-release Tablets and Marketed Nicotinic Acid Sustained-release Tablets

OBJECTIVE:To study the bioequivalence of Compound nicotinic acid(NA)bilayer sustained-release tablets and marketed NA sustained-release tablets. METHODS:A single dose of Compound NA bilayer sustained-release tablets(containing500 mg NA)and the marketed NA sustained release tablets(containing NA 500 mg)were administered to 6 dogs,respectively,according to the double periods and randomized crossover design. Blood concentration of NA was determined by HPLC within 12 h after medication. The pharmacokinetic parameters and relative bioavailability of NA were calculated with 3p97 software. RESULTS:The pharmacokinetic characteristics followed one-compartment model after oral administration of Compound NA bilayer sustained-release tablets and NA sustained-release tablets. Their main pharmacokinetic parameters were as follows:tmaxwere(5.2±1.4)h and(5.0±1.6)h;cmaxwere(77.3±10.8)μg/ml and(76.3±7.3)μg/ml;t1/2were(1.5±0.2)h and(1.4±0.2)h;AUC0-∞were(416.6±60.5)μg·h/ml and(377.5±50.7)μg·h/ml,respectively. The relative bioavailability of Compound NA bilayer sustained-release tablets was(111.1±14.8)%. 90% CI of cmaxand AUC0-∞of Compound NA bilayer sustained-release tablets were 87.0%-119.0% and 101.0%-120.0%. CONCLUSIONS:The difference of cmaxand AUC0-∞between 2 kinds of sustained-release tablets has no statistical significance;the 2 kinds of sustained-release tablets are bioequivalent.