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January 1, 2006The Journal of Clinical PharmacologyOpen Access

Pharmacokinetics of Otamixaban, a Direct Factor Xa Inhibitor, in Healthy Male Subjects: Pharmacokinetic Model Development for Phase 2/3 Simulation of Exposure

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Why the study?

What are the pharmacokinetic properties of intravenous otamixaban in healthy male subjects?

Population

Healthy male subjects

Design

Other

Authors

APAnne PaccalyRegeneron (United States)AFAnnke FrickSanofi (Germany)SRShashank RohatagiAmerican College of Sports Medicine

Discussion

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Implication

Supports PK-guided dosing in early trials; leaves open efficacy and safety in coronary thrombosis.

Structured PICO

What are the pharmacokinetic properties of intravenous otamixaban in healthy male subjects?

P
Population
Healthy male subjects
I
Intervention
Otamixaban administered intravenously over a wide range of doses (1-minute bolus to 24-hour infusions)
O
Outcome
Pharmacokinetic parameters (clearance, volume of distribution, dose-exposure relationship)surrogate

Otamixaban exhibits predictable pharmacokinetics with rapid distribution and elimination in healthy subjects, supporting its further development for coronary thrombosis.

Cite This Study

Paccaly et al. (2006) studied this question.

synapsesocial.com/papers/6a70143dc92390ac2d07b46ahttps://doi.org/10.1177/0091270005281817
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1First Experience With Direct Factor Xa Inhibition in Patients With Stable Coronary Disease2002 · 63 citations
  2. 2Antithrombotic efficacy of a novel factor Xa inhibitor, FXV673, in a canine model of coronary artery thrombolysis2001 · 25 citations
  3. 3Pharmacodynamic markers in the early clinical assessment of otamixaban, a direct factor Xa inhibitor2005 · 32 citations
  4. 4ACC/AHA Guidelines for the Management of Patients With Unstable Angina and Non–ST-Segment Elevation Myocardial Infarction: Executive Summary and Recommendations2000 · 4,502 citations
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