Journal de bioéquivalence et de biodisponibilité

Abstrait

Bioequivalence Study of Two Formulations of Cephalexin Powder For Oral Suspension in Healthy Subjects Under Fasting Conditions

Ginanjar VA*, Handayani LR, Yunaidi DA, Kurniawan YI, Saputro ID, Astuti PDY, Nima NS,Phuong LVN, Hieu NN

Objective: The present study was conducted to the bioavailability of two formulations of cephalexin 250 mg powderfor oral suspension administered in fasting condition in healthy subjects are equivalent.Materials and Method: This study was an open-label, randomized, single-dose, twoperiod, two-sequence, cross-overstudy under fasting condition which included 20 healthy adult male and female subjects under fasting condition.Blood samples were taken and analyzed for plasma concentration of cephalexin using selective and sensitive HPLC-UV method This study consisted of two periods, each 6 hours interspaced by washout period for 7 days betweendoses (test and reference). The pharmacokinetic parameters assessed in this study were the maximum plasmaconcentration (Cmax), the area under plasma concentration-time curve from time zero to the last observedconcentration(AUC0-t), the area under plasma concentration-time curve from time zero to infinity (AUC0-inf), thetime to achieve the maximum plasma concentration (tmax), and the terminal half-life (t½).Results: After a single-dose administration of cephalexin 250 mg powder for oral suspension, the mean (SD) valueAUC0-t and Cmax of test product were 19622.05 (5020.31) ng.h/mL and 13305.52 (3290.83) ng/mL, respectively;the mean (SD) value AUC0-t and Cmax of reference product were 19124.08 (3388.27) ng.h/mL and 14920.71(3404.05) ng/mL, respectively. The geometric mean ratios (90% CI) of the test drug/comparator drug for cephalexinwere 101.34% (97.48-105.35%) for AUC0-t and 88.78% (80.73-97.64%) for Cmax. There were thirteen adverse eventsreported during this study.Conclusion: The present study was concluded that two cephalexin powder for oral suspension formulations were bioequivalent