Pharmacokinetics and bioequivalance of nateglinide in healthy volunteers

Objective To study the pharmacokinetics and bioequivalence ofnateglinide capsule in 20 healthy male volunteers. Methods A single oral dose 90mgnateglinide of reference or test drugs was given to each volunteer according to anopen, randomized, cross-over study. The drug concentrations in plasma weredetermined by HPLC method. Results The main pharmacokinetic parameters ofnateglinide were as the following: AUC0-10 were(12.38±1.90)and (12.78±2.72)mg.h.L-1, Cmax were (4.93±1.08) and (4.88±1.06) mg.L-1, tmax were (2.40±0.31)and (2.32±0.34) h, t1/2ke were (2.06±0.70) and (2.08±0.76) h for test and reference,respectively. The relative bioavailability of AUC0-10 was (100.6±22.8)%. Conclusion The results of statistical analysis shown that two formulations were bioequivalent.