Assessment of relative bioavailability of two presentations of moroctocog alfa (AF‐CC) in subjects with moderately severe or severe hemophilia A. Issue 3 (27th October 2014)

• Record Type: Journal Article
• Authors: Shafer, Frank; Charnigo, Robert J.; Plotka, Anna; Baumann, James; Liang, Yali; Korth‐Bradley, Joan
• Is Part Of: Clinical pharmacology in drug development. Volume 4:Issue 3(2015:May/Jun.)
• Page Start: 237
• Page End: 241
• Publication Date: 2014-10-27
• Subjects: Drugs -- Testing -- Periodicals; Drug development -- Periodicals; Clinical pharmacology -- Periodicals; 615.580724
• DOI: 10.1002/cpdd.168
• Languages: English
• ISSNs: 2160-7648

Abstract

<abstract abstract-type="main" xml:lang="en"> <title>Abstract</title> <sec id="cpdd168-sec-0001" sec-type="section"> <p>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 AUC_inf, and C_max 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.</p> </sec> </abstract>