Comparative bioavailability and pharmacokinetics of two oral formulations of flurbiprofen: a single-dose, randomized, open-label, two-period, crossover study in Pakistani subjects

ABSTRACT

Comparative bioavailability studies are conducted to establish the bioequivalence of generic formulation with that of branded reference formulation, providing confidence to clinicians to use these products interchangeably. This study was carried out to compare a locally manufactured formulation of flurbiprofen with that of a branded product. Twenty two healthy male adults received a single dose of flurbiprofen [100mg] either generic or branded product according to randomization scheme on each of 2 periods. Blood samples were collected and plasma flurbiprofen concentration was determined by a validated HPLC method. Pharmacokinetic parameters like AUC[0-t], AUC[0- Infinity], C[max], T[max], t[1/2] Vd and clearance were determined. The 90% CI for the ratio of geometric means of test to reference product's pharmacokinetic variables was calculated. Pharmacokinetic parameters for two formulations were comparable. Ratio of means of AUC[0-24], AUC[0- Infinity] and C[max] for test to reference products and 90% CI for these ratios were within the acceptable range. The p-values calculated by TOST were much less than the specified value [p-0.05]. ANOVA gave p-values which were more than the specified value [p-0.05] for sequence, subject, period and formulation. Test formulation of flurbiprofen [tablet Flurso] was found to meet the criteria for bioequivalence to branded product [tablet Ansaid] based on pharmacokinetic parameters