Pharmacokinetics and bioequivalence of two ?-Lipoic acid preparations in Chinese healthy volunteers / 中国临床药理学与治疗学

ABSTRACT

AIM:To develop a high performance liquid chromatography -mass spectrometry method for the determination of ?-Lipoic acid in plasma,to study the pharmacokinetics of ?-Lipoic acid and evaluate the bioequivalence of two preparations in healthy subjects. METHODS:A single oral dose of 200 mg ?-Lipoic acid capsules and tablets was given to 22 healthy male volunteers according to an open randomized 2 way crossover design. Plasma concentrations of ?-Lipoic acid were determined by HPLC-MS method. The pharmacokinetic parameters and relative bioavailability were calculated to evaluate the bioequivalence of the two preparations. RESULTS:The pharmacokinetic parameters of the two products were as followstmax were (16?4) and (20?20) min,?max were (1490?359) and (1537?290) ng/mL,AUC0-t were (59559?18456) and (58210?15080) ng?mL-1?min,AUC0-∞ were (60068?18556) and (58634?15126) ng?mL-1?min,respectively. The relative bioavailability of AUC0-t and AUC0-∞ were (102.97?18.28)% and (103.09?18.26)%. CONCLUSION:The result demonstrated that two formations are bioequivalent by statistical analysis of variant,two one-side t-test and 90% confidential interval.