Bioequivalence of nicotinic acid sustained-release tablets in healthy volunteers

Objective To study the pharmacokinetics of nicotinic acid sustained-release tablets in healthy volunteers and evaluate the bioequivalence.Methods Single oral dose(1.5 g of test and reference formulations)were given to 30 volunteers in an open randomized crossover way.The concentrations of nicotinic acid in plasma were determined by HPLC-MS/MS.The pharmacokinetic parameters were calculated and the bioequivalence of two formulations were evaluated by DAS program.Results The main pharmacokinetic parameters of test and reference preparations obtained from single oral dose were as follows: AUC0-t were(20.05±16.29),(21.61±18.06)μg·h·mL-1;AUC0-∞ were(20.81±16.30),(22.81±18.47)μg·h·mL-1;Cmax were(8.72±6.81),(9.57±8.22)μg·mL-1;tmax were(4.41±1.34),(4.31±1.29)h;t1/2 were(4.00±4.90),(2.91±3.39)h.Conclusion The two preparations were bioequivalent.