Bioequivalence of Azihromycin Capsules in Healthy Volunteers
- VernacularTitle:阿奇霉素胶囊人体生物等效性研究
- Author:
Minghong OU
- Publication Type:Journal Article
- Keywords:
Azihromycin capsules;
Pharmacokinetics;
Bioequivalence
- From:
China Pharmacy
2001;0(10):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To study the bioequivalence of azihromycin capsules in healthy volunteers. METHODS: 21 healthy volunteers designed by latin square were divided into group A, B and C. The three groups were given single dose of azihromycin capsules 1(0.25 g in every capsule), azihromycin capsules 2(0.125 g in every capsule) and reference preparation(0.25 g in every capsule). The plasma concentrations of azihromycin were determined by microbiological assay and pharmacokinetic parameters were calculated and the bioequivalence was evaluated. RESULTS: Main pharmacokinetic parameters of three kinds of preparations were as follows:Cmax(1.06?0.41)?g?mL-1,(0.99?0.54) ?g?mL-1 and (1.07?0.53) ?g?mL-1; tmax(2.38?0.86)h, (1.86?0.85)h and (2.52?1.40)h; AUC0～144(11.00?6.15)?g?h?mL-1,(10.65?5.17) ?g?h?mL-1 and (10.49?5.17)?g?h?mL-1;AUC0～∞(12.48?7.27)?g?h?mL-1,(11.65?5.64)?g?h?mL-1 and (11.57?5.87)?g?h?mL-1. The relative bioavailabitity of azihromycin capsules 1 and azihromycin capsules 2 were (102.73?15.63)% and (103.17?13.64)%. CONCLUSION: The results suggest that two specifications of azihromycin capsules are bioequivalent to reference preparation.
