Why the study?
A population pharmacokinetic model of rivaroxaban was needed to provide relevant pharmacokinetic parameters and covariate information for further studies in healthy volunteers and patients with non-valvular atrial fibrillation.
What are the population pharmacokinetic parameters and appropriate dosing of rivaroxaban in healthy volunteers and Chinese patients with NVAF?
What are the population pharmacokinetic parameters and appropriate dosing of rivaroxaban in healthy volunteers and Chinese patients with NVAF?
Population pharmacokinetic modeling suggests a 15 mg daily dose of rivaroxaban is appropriate for Chinese patients with NVAF, with dose reduction required for moderate renal impairment.
The PopPK model of rivaroxaban in healthy volunteers and patients with NVAF developed in this study was expected to help provide relevant PK parameters and covariate information for further studies of rivaroxaban. The study indicated that a daily dose of 15 mg may be appropriate as the primary dosage of rivaroxaban for Chinese patients with NVAF. A lower dose is recommended for patients with moderate renal impairment to avoid overexposure.
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Gu et al. (2025) studied this question.
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