title: Assessment of relative bioavailability of two presentations of moroctocog alfa (AF-CC) in subjects with moderately severe or severe hemophilia A.
abstract: An open-label, single-dose, randomized, two-period, cross-over study comparing the pharmacokinetics of factor VIII activity in plasma (
  
  
  
  C) after administration of a new presentation of moroctocog alfa containing 3,000 IU in a dual-chamber syringe and the combined contents of approved 1,000 and 2,000 IU vials was conducted in 16 male subjects who had moderately severe or severe hemophilia A (FVIII:C ≤2 IU/dL). Blood samples were collected for 72 hours after administration of the dose.
  
  
  
  C were assayed using a chromogenic substrate assay in a central laboratory. The
  
  
  
  C pharmacokinetic parameters were calculated using noncompartmental analysis. The dual-chamber syringe would be bioequivalent to the combined contents of the vials if the 90% confidence limits of the ratio of the geometric mean values of AUCinf , and Cmax fell within the interval of 80-125%. The bioequivalence criteria were met. A total of seven treatment related adverse events were observed in a total of five subjects. All were mild and none was determined to be related to administration of study medication.
authors.affiliation: Pfizer Inc, Collegeville, PA, USA.
authors.forename: Frank
authors.initials: F
authors.lastname: Shafer
authors.affiliation: Pfizer Inc, Collegeville, PA, USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Charnigo
authors.affiliation: Pfizer Inc, Collegeville, PA, USA.
authors.forename: Anna
authors.initials: A
authors.lastname: Plotka
authors.affiliation: Pfizer Inc, Collegeville, PA, USA.
authors.forename: James
authors.initials: J
authors.lastname: Baumann
authors.affiliation: Pfizer Inc, Groton, CT, USA.
authors.forename: Yali
authors.initials: Y
authors.lastname: Liang
authors.affiliation: Pfizer Inc, Collegeville, PA, USA.
authors.forename: Joan
authors.initials: J
authors.lastname: Korth-Bradley
mesh_terms: D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D018592:Cross-Over Studies; D004339:Drug Compounding; D005060:Europe; D005169:Factor VIII / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D006207:Half-Life; D006467:Hemophilia A / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D006487:Hemostasis / Q000187:drug effects*; D006490:Hemostatics / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D008954:Models, Biological; D012720:Severity of Illness Index; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D006490:Hemostatics; C427184:recombinant factor VIII SQ; D005169:Factor VIII
keywords: factor VIII; hemophilia A; moroctocog alfa; pharmacokinetics