STUDY ON PHARMACOKINETICS AND BIOEQUIVALENCE OF RSIFN-CO IN HEALTHY VOLUNTEERS

[Objective]To study the pharmacokinetics and bioequivalence of Lyophilized Recombinant Super Compound Interferon(rSIFN-co).[Methods]A single subcutaneous injection dose of rSIFN-co from either 9μg test injection or its 9μg reference injection Infergen was given to 18 healthy male volunteers by a randomized cross-over design. The concentration in plasma of 2′5′-OAS,a active metabolity of interferon,was determined by radioimmunoassay(RIA)method. The pharmacokinetics and bioequivalence of the test injection were compared with the reference injection.[Results]The main pharmacokinetics parameters of test injection and reference injection were as follow:AUC0-48 were 4184.1±1938.7pmol·h/dL and 3336.8±1365.5 pmol·h/dL respectively,Cmax were 204.42±100.16 pmol·dL-1 and 271.77±150.53 pmol·dL-1 respectively,rTmax were 23.00±1.03 h and 23.22±1.0 h respectively. Through the one two-sided test and the analysis of covariance,no significant difference between the Tmax of the two formulations was found(P = 0.163). However,the Cmax and AUC0-48 of the test rSIFN-co was higher than that of reference Infergen(P = 0.031,P = 0.014). The relative bioavailability of the test rSIFN-co was 125.4% of the reference injection.[Conclusion]The two formulations are bioequivalent,the injectable powder of rSIFN-co has clinical popularization value.