Relative Bioavailability of Clarithromycin Capsule in Healthy Volunteers
- VernacularTitle:克拉霉素胶囊相对生物利用度研究
- Author:
Zhou JIANG
;
Hua MENG
;
Ning WANG
- Publication Type:Journal Article
- Keywords:
Clarithromycin;
pharmacokinetics;
bioavailability
- From:
China Pharmacy
2001;0(07):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To evaluate the relative bioavailability of two products(CLMC 1 ,CLMC 2 )of Clarithromycin in man.METHODS:A single oral500mg dose of CLMC 1 or CLMC 2 was given to20healthy male volunteers in an open randomized crossover study.The plasma concentrations of CLMC 1 and CLMC 2 were measured by microbial assay.The pharmacokinetic parameters were calculated with3p97pharmacokinetic program and the bioequivalence was evaluated.RESULTS:The con?centration-time curves of CLMC 1 and CLMC 2 fitted to a two-compartent open model.C max were(2.23?0.83)?g/ml and(2.14?0.70)?g/ml;T max were(1.95?0.39)h,(1.78?0.41)h;AUC (0～T) were(9.50?2.52)(?g?h)/ml,(9.35?2.54)(?g?h)/ml respectively.The relative bioavailability of CLMC 1 was(101.60?9.35)%.CONCLUSION:The results of two and one-side t tests suggest that the CLMC 1 is bioequivalent with the CLMC 2 .
