Assessment of bioequivalence of a generic cyclosporine (Equoral) by a prospective randomized controlled trial on allogeneic stem cell transplant recipients.

INTRODUCTION

Bioequivalence of Equoral has been suggested by measurements of pharmacokinetic parameters in healthy volunteers and in stable renal transplant recipients, but not study in allogeneic stem cell transplant (ASCT) recipients. The aim of our study was to compare the pharmacokinetics and safety of Equoral to Neoral solution among ASCT recipients.

PATIENTS AND METHODS

Our open-label, two-way crossover, randomized controlled trial compared Equoral versus Neoral solutions in ASCT recipients. The 30 enrolled patients from June 2007 to November 2008 had a 7 to 14-day duration of the test period. A 10-point blood sampling from 0 to 12 hours measured Cmax (extent of absorption), tmax (rate of absorption) and AUC(0-12h) (area under the concentration-time curve) calculated by the linear trapezoid rule. The study protocol was approved by the ethics committee.

RESULTS

Median age was 26 years (range = 6-47). The mean pharmacokinetic features were: AUC(0-12h): Equoral 4162 ± 1231 ng·mL/h vs Neoral 4370 ± 1059 ng·mL/h (P = .50); Cmax: Equoral 821 ± 244 ng/mL vs Neoral 834 ± 298 ng/mL (P = .86); and tmax: 105 minutes for both formulations. Comparable toxicities and rates of graft-versus-host disease were recorded in both groups.

CONCLUSION

We suggest that Equoral and Neoral solution can be considered interchangeable in ASCT recipients.