Bioequivalence of domestic and imported terbinafine hydrochloride in healthy volunteers

Objective To evaluate the bioavailability and bioequivalence of domestic and imported terbinafine hydrochloride in healthy volunteers. Methods By self-control design,20 health volunteers were randomly divided into two groups and oral administrated with test preparation(domestic) and reference preparation(imported). The elution time is one week. The plasma concentrations of terbinafine were measured simultaneously by HPLC. The pharmacokinetic parameters were calculated with DAS 2.0 pharmacokinetic software. The biological availability of the imported and domestic preparations was compared. Results The pharmacokinetic parameters of the imported and domestic preparations were as follows,t1/2 were(17.26±7.60),(17.94±7.94) h;AUC0～t were(5.20±2.06),(4.90±1.50) mg·h·L-1;AUC0～∞ were (5.70±2.24),(5.40±1.74)mg·h·L-1;Cmax were(1.15±0.48),(1.03±0.36)mg·L-1;tmax were(1.56±0.74),(1.36±0.50)h. The relative bioavailability of terbinafine was 104.4%. Conclusion The test preparation showed to be bioequivalence to the reference preparation.