Bioequivalence of huperzine A sustain-release tablets in healthy volunteer

Objective To study the bioavailability of the tested and reference huperzine A sustain-release tablets in healthy male volunteers.Methods According to the four-crossing design,each volunteer was orally given huperzine A sustain-release tablets or huperzine A.The plasma concentrations were determined by LC-MS/MS.Pharmacokinetic parameters were obtained using DAS 2.0 program.Results The main pharmacokinetic parameters of huperzine A tablets test and reference were as follows: Cmax were(0.75±0.25),(1.57±0.44)ng·mL-1,Tmax were(5.77±3.60),(1.27±0.98)h,AUC0–t were(14.4±5.81),(15.1±5.66)ng·h·mL-1,AUC0-∞ were(17.1±7.29),(16.7±6.77)ng·h·mL-1,in 200 μg groups respectively.The relative bioavailability was(97.2± 24.4)%.The data of the reference and tested drugs were not different as shown by F test.Conclusion The result shows that the two huperzine A tablets made in two different preparations are bioequivalent.Huperzine A sustain-release tablets clearly have the characteristic of slow releasing properties.