The DOI matches its Crossref record; 9 of the 9 references it cites were found in a registry or an index.
Effect of Food, an Antacid, and the H2 Antagonist Ranitidine on the Absorption of BAY 59–7939 (Rivaroxaban), an Oral, Direct Factor Xa Inhibitor, in Healthy Subjects
Abstract
To investigate the influence of food and administration of an antacid (aluminum‐magnesium hydroxide) or ranitidine on the absorption of BAY 59–7939 (rivaroxaban), 4 randomized studies were performed in healthy male subjects. In 2 food interaction studies, subjects received BAY 59–7939, either as two 5‐mg tablets (fasted and fed), four 5‐mg tablets (fasted), or one 20‐mg tablet (fasted and fed). In 2 drug interaction studies, BAY 59–7939 (six 5‐mg tablets) was given alone or with ranitidine (150 mg twice daily, preceded by a 3‐day pretreatment phase) or antacid (10 mL). Plasma samples were obtained to assess pharmacokinetic and pharmacodynamic parameters of BAY 59–7939. In the presence of food, time to maximum concentration (t max) was delayed by 1.25 hours; maximum concentration (C max) and area under the curve (AUC) were increased, with reduced interindividual variability at higher doses of BAY 59–7939. Compared with baseline, BAY 59–7939 resulted in a relative increase in maximum prothrombin time (PT) prolongation of 44% (10 mg) and 53% (20 mg) in the fasted state, compared with 53% and 83% after food. Time to maximum PT prolongation was delayed by 0.5 to 1.5 hours after food, with no relevant influence of food type. No significant difference in C max and AUC was observed with coadministration of BAY 59–7939 and ranitidine or antacid.
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Cites
The Pharmacology and Management of the Vitamin K Antagonists
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Effects of Food on Clinical Pharmacokinetics
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New anticoagulants: beyond heparin, low‐molecular‐weight heparin and warfarin
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Cited by
Steffel, J., Verhamme, P., Potpara, T. S., Albaladejo, P., Antz, M., Desteghe, L., Haeusler, K. G., Oldgren, J., Reinecke, H., Roldan-Schilling, V., et al. (2018) · European Heart Journal · doi:10.1093/eurheartj/ehy136 · Cited by 2,123
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Eerenberg, E. S., Kamphuisen, P. W., Sijpkens, M. K., Meijers, J. C., Buller, H. R., & Levi, M. (2011) · Circulation · doi:10.1161/circulationaha.111.029017 · Cited by 1,361
Steffel, J., Collins, R., Antz, M., Cornu, P., Desteghe, L., Haeusler, K. G., Oldgren, J., Reinecke, H., Roldan-Schilling, V., Rowell, N., et al. (2021) · EP Europace · doi:10.1093/europace/euab065 · Cited by 1,132
Heidbuchel, H., Verhamme, P., Alings, M., Antz, M., Diener, H.-C., Hacke, W., Oldgren, J., Sinnaeve, P., Camm, A. J., & Kirchhof, P. (2015) · Europace · doi:10.1093/europace/euv309 · Cited by 1,113
Metadata
- Authors
- Kubitza, D., Becka, M., Zuehlsdorf, M., & Mueck, W.
- Venue
- The Journal of Clinical Pharmacology
- Publisher
- Wiley
- Published
- 2006-05
- Volume
- 46
- Issue
- 5
- Pages
- 549-558
- ISSN
- 0021-9754 (ISSN-L)
- 0091-2700
- 1552-4604
- OpenAlex
- W2075341962
- Cited by
- 254
- References
- 9
- FWCI
- 10.96
- Type
- journal article
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: Effect of Food, an Antacid, and the H2 Antagonist Ranitidine on the Absorption of BAY 59–7939 (Rivaroxaban), an Oral, Direct Factor Xa Inhibitor, in Healthy Subjects. https://app.cochat.ai/papers/10.1177/0091270006286904
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- Kubitza, D., Becka, M., Zuehlsdorf, M., & Mueck, W. (2006). Effect of Food, an Antacid, and the H2 Antagonist Ranitidine on the Absorption of BAY 59–7939 (Rivaroxaban), an Oral, Direct Factor Xa Inhibitor, in Healthy Subjects. The Journal of Clinical Pharmacology. https://doi.org/10.1177/0091270006286904
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