Thromb Haemost 1997; 78(02): 871-875
DOI: 10.1055/s-0038-1657644
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Absolute and Comparative Subcutaneous Bioavailability of Ardeparin Sodium, a Low Molecular Weight Heparin

Steven Troy
1  The Clinical Research and Development Wyeth-Ayerst Research, Philadelphia, PA, USA
,
Richard Fruncillo
2  The Clinical Pharmacology Unit, Graduate Hospital, Philadelphia, PA
,
Tsunenori Ozawa
3  The Wayne State University, C. S. Mott Center, Detroit, Ml, USA
,
Eberhard Mammen
3  The Wayne State University, C. S. Mott Center, Detroit, Ml, USA
,
Scott Holloway
1  The Clinical Research and Development Wyeth-Ayerst Research, Philadelphia, PA, USA
,
Soong Chiang
1  The Clinical Research and Development Wyeth-Ayerst Research, Philadelphia, PA, USA
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Publikationsverlauf

Received 17. 1996

Accepted after revision 26. März 1997

Publikationsdatum:
12. Juli 2018 (online)

Summary

Ardeparin sodium (Normiflo®, Wyeth-Ayerst) is a low molecular weight heparin undergoing clinical evaluation as an antithrombotic agent. The objective of this study was to evaluate the absolute and comparative bioavailability of ardeparin following subcutaneous administration of three different formulations [two formulations of ardeparin at 10,000 anti-factor Xa (aXa) U/ml, but with different preservatives, and a 20,000 aXa U/ml formulation]. The study was conducted using a randomized 4-period crossover design (three subcutaneous treatments and one intravenous treatment) in 24 healthy subjects, and the pharmacokinetics of ardeparin were characterized by plasma anti-factor Ila (alia) and anti-factor Xa (aXa) activities. The mean absolute bioavailability of ardeparin based on alia activity ranged from 62% to 64% and the mean absolute bioavailability based on aXa activity ranged from 88% to 97%. Based on bioequivalence testing criteria, the three ardeparin formulations were bioequivalent.