Pharmacokinetics and bioequivalence of two α-Lipoic acid preparations in Chinese healthy volunteers

AIM:To develop a high performance liquid chromatography -mass spectrometry method for the determination of α-Lipoic acid in plasma,to study the pharmacokinetics of α-Lipoic acid and evaluate the bioequivalence of two preparations in healthy subjects. METHODS:A single oral dose of 200 mg α-Lipoic acid capsules and tablets was given to 22 healthy male volunteers according to an open randomized 2 way crossover design. Plasma concentrations of α-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 follows:tmax were (16±4) and (20±20) min,ρmax 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.