Bioequivalence of Roxithromycin Tablets in Healthy Volunteers / 中华医院感染学杂志
Chinese Journal of Nosocomiology
; (24)2006.
Article
em Zh
| WPRIM
| ID: wpr-587350
Biblioteca responsável:
WPRO
ABSTRACT
OBJECTIVE To study the relative bioequivalence of two sorts of domestic roxithromycin tablets. METHODS The randomized and crossover study was conducted in 18 healthy volunteers. After a single dose of the drugs given, their plasma drug concentration was determined by microbioassay. RESULTS Both the two sorts of domestic roxithromycin tablets were fitted to one compartment model. The main pharmacokinetic parameters of the tested and reference roxithromycin were as follows: C_ max (10.869?2.671) ?g/ml and (11.250?3.097)?g/ml; T_ max (1.7?0.8)h and (1.6?0.8) h; t_ 1/2 (13.407?2.391)h and (12.496?2.231) h; AUC_ 0-tn (127.097?32.971)?g?ml~ -1 ?h and (134.429?35.783) ?g?ml~ -1 ?h;AUC_ 0-∞ (136.556?33.958)?g?ml~ -1 ?h and (143.483? 38.052 ) ?g?ml~ -1? h; F_ 0-tn and F_ 0-∞ were (95.79?17.46)% and (96.58?16.66)%, respectively. CONCLUSIONS The results of analysis showed that the tested and reference formulations are bioequivalent.
Texto completo:
1
Índice:
WPRIM
Tipo de estudo:
Clinical_trials
Idioma:
Zh
Revista:
Chinese Journal of Nosocomiology
Ano de publicação:
2006
Tipo de documento:
Article