Assessment of Relative Bioavailability of Moroctocog Alfa and Moroctocog Alfa (AF‐CC) in Subjects With Severe Hemophilia A

An open‐label, single‐dose, randomized, two‐period, crossover study comparing the pharmacokinetics of factor VIII activity in plasma (FVIII:C) after administration of an albumin‐free presentation of moroctocog alfa (test) and moroctocog alfa manufactured using the previous technique (reference) was conducted in 30 (25 evaluable) male subjects who had severe hemophilia A (FVIII:C < 1 IU/dL). Blood samples were collected for 48 h after administration of each dose. FVIII:C was assayed using a chromogenic substrate assay. The FVIII:C pharmacokinetic parameters were calculated using noncompartmental analysis. The presentations would be bioequivalent if the 90% confidence limits of the ratio of the geometric mean values of AUC(inf) and recovery fell within the interval of 80–125%. The bioequivalence criteria were met. A total of 10 treatment‐related adverse events were observed in a total of nine subjects. All were mild and none was determined to be related to administration of study medication.