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Cited by 334

The DOI matches its Crossref record; 16 of the 16 references it cites were found in a registry or an index.

Body Weight Has Limited Influence on the Safety, Tolerability, Pharmacokinetics, or Pharmacodynamics of Rivaroxaban (BAY 59‐7939) in Healthy Subjects

Kubitza, Dagmar, Becka, Michael, Zuehlsdorf, Michael, Mueck, Wolfgang·2007·The Journal of Clinical Pharmacology

Abstract

Anticoagulants are often dose adjusted, or their use restricted, in patients with extremes of body weight. Rivaroxaban (BAY 59‐7939) is a novel, oral, direct factor Xa inhibitor in clinical development. This was a randomized, single‐blind, placebo‐controlled, parallel‐group study in healthy male and female subjects to assess the effect of extreme body weight (≤50 kg and >120 kg), and gender, on the safety, tolerability, pharmacokinetics, and pharmacodynamics of rivaroxaban 10 mg, compared with subjects of normal weight (70–80 kg). Rivaroxaban was well tolerated. Cmax of rivaroxaban was unaffected in subjects >120 kg but was increased by 24% in subjects weighing ≤5 0 kg, resulting in a small (15%) increase in prolongation of prothrombin time, which was not considered clinically relevant. The area under the curve was unaffected by body weight or gender. No other clinically relevant differences were observed, suggesting that rivaroxaban is unlikely to require dose adjustment for body weight or gender.

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Metadata

Authors
Kubitza, D., Becka, M., Zuehlsdorf, M., & Mueck, W.
Venue
The Journal of Clinical Pharmacology
Publisher
Wiley
Published
2007-02
Volume
47
Issue
2
Pages
218-226
ISSN
  • 0021-9754 (ISSN-L)
  • 0091-2700
  • 1552-4604
OpenAlex
W2074947904
Cited by
334
References
16
FWCI
10.56
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: Body Weight Has Limited Influence on the Safety, Tolerability, Pharmacokinetics, or Pharmacodynamics of Rivaroxaban (BAY 59‐7939) in Healthy Subjects. https://app.cochat.ai/papers/10.1177/0091270006296058
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Kubitza, D., Becka, M., Zuehlsdorf, M., & Mueck, W. (2007). Body Weight Has Limited Influence on the Safety, Tolerability, Pharmacokinetics, or Pharmacodynamics of Rivaroxaban (BAY 59‐7939) in Healthy Subjects. The Journal of Clinical Pharmacology. https://doi.org/10.1177/0091270006296058

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Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.