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Assessment of relative bioavailability of two presentations of moroctocog alfa (AF‐CC) in subjects with moderately severe or severe hemophilia A
Author(s) -
Shafer Frank,
Charnigo Robert J.,
Plotka Anna,
Baumann James,
Liang Yali,
KorthBradley Joan
Publication year - 2014
Publication title -
clinical pharmacology in drug development
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.711
H-Index - 22
eISSN - 2160-7648
pISSN - 2160-763X
DOI - 10.1002/cpdd.168
Subject(s) - bioequivalence , medicine , vial , pharmacokinetics , confidence interval , bioavailability , adverse effect , pharmacology , anesthesia , chromatography , chemistry
Abstract 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.