The study was conducted with the aim of evaluating bioequivalence, relative
silability and efficacy of deferiprone manufactured locally (Ferinil, Global
aceutical, Pakistan) with a reference drug (Ferriprox, ApoPharma, Canada) in healthy
volunteers. It was a randomized crossover study enrolling 12 volunteers within age limit
g·55yrs and meeting the inclusion and exclusion criteria of the study, Each volunteer was
administered two tablets of deferiprone 500mg of both reference and test drug with a two-
washout period. Blood samples of about 5ml was collected at 0, 0.25, 0.5, 0.75, 1, 1.5, 5,4, 6, 8, 12 hour at predetermined time intervals and one sample was taken as control
giving first dose to volunteers. Heparinized vacuette was used for collection of blood
les. After sampling, blood samples was centrifuged at approximately 3000 rpm for 10
les and then stored at -80°C till analyzed. Plasma deferiprone levels were analyzed using
led High pressure liquid chromatography (HPLC) method. Pharmacokinetic parameters
calculated from plasma concentration time curve non-compartmentally and two-
artmental. After logarithmic transformation of data statistical comparisons of Cmax,
(0-1), AUC(o.oo) was calculated and appropriate statistical method was used for calculation. mean relative bioavailability was 104% and was proved to be bioavailable. The Cmax
(mean ±SD) for reference and test drug was 12.68 ± 4.91 and 14.41 ± 5.04 ug/ml,
ctively while average ± SD of AUCO-t and AUCO-inf of test and reference drug was 40.49
6,05 and 42.84 ± 18.47 ugh/ml and 38.63 ± 13.65 and 40.75 ± 14.17 ugh/ml. Average
(test/reference) of Cmax 90% CI was 0.9876-1.3125. Average ratio (test/reference) of
Co.190% CI was 0.9737-1.1150, and of AUCo-inf 90% CI was 0.9542-1.1343. Therefore both test and reference drug was fairly tolerated by volunteers and no adverse event was
detected. Hence, the average ratio of 90% confidence interval of AUCo-t and AUCO-inf was
0.9737-1.1150 and 0.9542-1.1343 that lie within the acceptable limit of (0.80 - 1.25) for
bioequivalence acceptance. Effectiveness of deferiprone depends on AUC instead of Cmax therefore the average ratio of 90% confidence interval of Cmax was 0.9876-1.3125 that lie
with the acceptable limit of WHO bioequivalence acceptance (0.75 - 1.33). ANOVA show
no significant variations among drug, period and sequence effect. Therefore, it was concluded
that Ferriprox was proved to be bioequivalent in healthy male Pakistani volunleers.