Bioequivalence Study of Azacitidine for Injection 100 mg “Sawai” in Patients with Myelodysplastic Syndromes（MDS）

Abstract

To evaluate the bioequivalence of the generic product Azacitidine for injection 100 mg “Sawai” and the branded product Vidaza^® for injection 100 mg, a two-period, two-way crossover study was conducted in 35 Japanese patients with myelodysplastic syndromes (MDS) who were being treated with azacitidine. The MDS patients were subcutaneously administered 100 mg (one vial) of either “Sawai” or Vidaza^® on Days 1 and 2 within the same treatment cycle of azacitidine regimen. Plasma azacitidine concentrations were determined up to 4 hours after administration. Treatment with the patients' usual dose of Vidaza^® was continued on and after Day 3.
AUC_t and Cmax of both products were calculated from the plasma azacitidine concentrations up to 4 hours after administration on Days 1 and 2 to assess bioequivalence. The 90％ confidence interval of difference in the average values of the generic and branded products was within the acceptable range of log (0.80) ‒log (1.25) described in the Guideline for Bioequivalence Studies of Generic Products. All adverse events were confirmed as recovered or recovering at the time of last observation, and the safety profiles of both products were similar.

The results suggest that Azacitidine for injection 100 mg “Sawai” and Vidaza^® are bioequivalent and therapeutically equivalent.