Bioequivalence of brodimoprim capsules in 18 healthy volunteers / 中国临床药理学与治疗学

ABSTRACT

Aim To evaluate the bioequivalence of demestic brodimoprim capsules and imported hyprim tablets and provide experimental basis for clinical application. MethodsA single dosage of Brodimoprim or hyprim was given to 18 healthy volunteers in a randomized 2-way cross-over test and the brodimoprim concentrations in plasma were determined by HPLC with β-naphtol as internal standard. The pharmacokinetic parameters and the relative bioavailability of the two preparations were calculated and their bioequivalence was evaluated. ResultsThe major pharmacokinetic parameters of test and reference preparations were as follows respectivelyt1/2(α) (2.1 + 1.0) and (1.9+± 0.9) h, t1/3(β)(43.2±4.8) and (42.4±4.3)h, Tpeak(3.4±1.6) and (3.1±1.5) h,Cmax(5.9+ 0.9) and (5.9±1.0)μg · ml-1, AUC0～132(360.2± 55.3) and (358.7±52.6) μg · h · ml-1, AUC0～∞ (423.8±56.0) and (422.5±51.1) μg · h · ml-1. The relative bioavailability(F) of brodimprim capsules was (99.7± 4.8)%。 Conclusion . The multi-factorial analysis of variance showed that there was no significant difference in AUC0- 132between the test and reference preparations (P＞ 0.05) . The bioequivalent assumption was proved by further two one-side t-test and (1～2 α) confidence interval analysis in individuals, periods and forms of these two preparations.