Pharmacokinetics and bioequivalence of dirithromycin tablet in Chinese human volunteers

Objective To study the pharmacokinetics and bioequivalence of the tested and referenced dirithromycin tablets in 20 healthy volunteers. Methods According to the crossover design, each volunteer was orally given 500mg dirithromycin. The serum concentrations were determined by microbioassay. Pharmacokinetic parameters were obtained using DAS programe .Results After a single oral dose 0.5g, t1/2β were 35.56 ±12.12 and 30.02 ±13.28h , Cmax were 0.50 ±0.14, 0.50 ±0.15 mg·L-1 at 4.3 ±1.0 and 4.9±0.15 h and AUC0-48 was 2.59 ±0.46 and 2.60 ±0.39 mg·h-L-1 for domestic and imported tablets, respectively. Relative bioavailability of the tested dirithromycin was(100.25 ±15.65)%. Conclution The result show that two tablets are bioequivalent.