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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

From Bayer HealthCare AG, Wuppertal, Germany.

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.

Key Words: Direct Factor Xa inhibitor • BAY 59-7939 • food • ranitidine • antacid

Address for reprints: Dagmar Kubitza, MD, Institute of Clinical Pharmacology, Bayer HealthCare AG, D-42096 Wuppertal, Germany; e-mail: dagmar.kubitza{at}bayerhealthcare.com.

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