title: Assessment of bioequivalence of a generic cyclosporine (Equoral) by a prospective randomized controlled trial on allogeneic stem cell transplant recipients.
abstract: BACKGROUND
  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.
  
  
  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.
  
  
  CONCLUSIONS
  We suggest that Equoral and Neoral solution can be considered interchangeable in ASCT recipients.
authors.affiliation: Centre National de Greffe de Moelle Osseuse, Tunis, Tunisia.
authors.forename: B O
authors.initials: BO
authors.lastname: Tarek
authors.forename: B F
authors.initials: BF
authors.lastname: Nadia
authors.forename: K
authors.initials: K
authors.lastname: Anis
authors.forename: L
authors.initials: L
authors.lastname: Saloua
authors.forename: A
authors.initials: A
authors.lastname: Abderrahmane
authors.forename: T
authors.initials: T
authors.lastname: Lamia
authors.forename: L
authors.initials: L
authors.lastname: Amel
authors.forename: L
authors.initials: L
authors.lastname: Mohamed
mesh_terms: D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D002648:Child; D018592:Cross-Over Studies; D016572:Cyclosporine / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D016568:Drugs, Generic / Q000009:adverse effects / Q000493:pharmacokinetics*; D006086:Graft vs Host Disease / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D008875:Middle Aged; D011446:Prospective Studies; D033581:Stem Cell Transplantation / Q000009:adverse effects; D013810:Therapeutic Equivalency; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D014416:Tunisia; D055815:Young Adult
chemical_list: D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D016572:Cyclosporine