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  • Title: Assessment of relative bioavailability of two presentations of moroctocog alfa (AF-CC) in subjects with moderately severe or severe hemophilia A.
    Author: Shafer F, Charnigo RJ, Plotka A, Baumann J, Liang Y, Korth-Bradley J.
    Journal: Clin Pharmacol Drug Dev; 2015; 4(3):237-41. PubMed ID: 27140804.
    Abstract:
    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.
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