The bioequivalence of oxaprozin enteric tablet in healthy volunteers measured with HPLC / 中国药理学通报
Chinese Pharmacological Bulletin
; (12)1987.
Article
em Zh
| WPRIM
| ID: wpr-558378
Biblioteca responsável:
WPRO
ABSTRACT
Aim An HPLC method was established for the study on pharmacokinetics and bioequivalence of oxaprozin enteric tablet in healthy volunteers.Methods The oxaprozin in plasma was determined using HPLC method following a single oral dose of 400 mg of oxaprozin given respectively to 18 healthy male volunteers in an open randomized crossover design.The pharmacokinetic parameters and relative bioavailability were calculated to evaluate the bioequivalence of 2 preparations.Results AUC_(0-240 h) of oxaprozin tested tablet and reference tablet were(2852.86?871.00)and (2992.84?854.02)?g?L~(-1)?h,C_(max) were(33.48?11.36)and (32.70?7.30)?g?L~(-1),T_(max) were(12.1?5.7)and(13.8?5.8)h,T_(1[]2ke) were(57.11?8.51)and(60.98?7.97)h,respectively.These main pharmacokinetic parameters obtained showed no statistically significant difference between the 2 products.Conclusion The method is simple and sensitive.Both preparations are bioequivalent.
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Base de dados:
WPRIM
Tipo de estudo:
Clinical_trials
Idioma:
Zh
Ano de publicação:
1987
Tipo de documento:
Article