Assessment of relative bioavailability of two presentations of moroctocog alfa (AF-CC) in subjects with moderately severe or severe hemophilia A.

UNLABELLED

An open-label, single-dose, randomized, two-period, cross-over study comparing the pharmacokinetics of factor VIII activity in plasma (

FVIII

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.

FVIII

C were assayed using a chromogenic substrate assay in a central laboratory. The

FVIII

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.