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Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factorXa inhibitor, in healthy subjects
Open accessAbstract
AIM: Apixaban is an oral factor Xa inhibitor approved for stroke prevention in atrial fibrillation and thromboprophylaxis in patients who have undergone elective hip or knee replacement surgery and under development for treatment of venous thromboembolism. This study examined the safety, pharmacokinetics and pharmacodynamics of multiple dose apixaban. METHOD: This double-blind, randomized, placebo-controlled, parallel group, multiple dose escalation study was conducted in six sequential dose panels - apixaban 2.5, 5, 10 and 25 mg twice daily and 10 and 25 mg once daily- with eight healthy subjects per panel. Within each panel, subjects were randomized (3:1) to oral apixaban or placebo for 7 days. Subjects underwent safety assessments and were monitored for adverse events (AEs). Blood samples were taken to measure apixaban plasma concentration, international normalized ratio (INR), activated partial thromboplastin time (aPTT) and modified prothrombin time (mPT). RESULTS: Forty-eight subjects were randomized and treated (apixaban, n = 36; placebo, n = 12); one subject receiving 2.5 mg twice daily discontinued due to AEs (headache and nausea). No dose limiting AEs were observed. Apixaban maximum plasma concentration was achieved ~3 h post-dose. Exposure increased approximately in proportion to dose. Apixaban steady-state concentrations were reached by day 3, with an accumulation index of 1.3-1.9. Peak : trough ratios were lower for twice daily vs. once daily regimens. Clotting times showed dose-related increases tracking the plasma concentration-time profile. CONCLUSION: Multiple oral doses of apixaban were safe and well tolerated over a 10-fold dose range, with pharmacokinetics with low variability and concentration-related increases in clotting time measures.
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“Hence, the more favorable bleeding profile is proposed to be a result of the decreased peak-to-trough ratios afforded by twice-daily DOAC dosing. 19”
From Systematic review and meta-analysis of the efficacy and safety of apixaban compared to rivaroxaban in acute VTE in the real world (2019) · cites this paper as [19]
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Metadata
- Authors
- Frost, C., Nepal, S., Wang, J., Schuster, A., Byon, W., Boyd, R. A., Yu, Z., Shenker, A., Barrett, Y. C., Mosqueda‐Garcia, R., & LaCreta, F.
- Affiliations
- Princeton University (US)
- Pfizer (United States) (US)
- Corresponding author
- Frost, Charles
- Venue
- British Journal of Clinical Pharmacology
- Publisher
- Wiley
- Published
- 2013-10-21
- Volume
- 76
- Issue
- 5
- Pages
- 776-786
- ISSN
- 0306-5251 (ISSN-L)
- 1365-2125
- PMC
- PMC3853536
- OpenAlex
- W1568662837
- Cited by
- 286
- References
- 35
- Citations by year
- 2026: 11 · 2025: 10 · 2024: 14 · 2023: 23 · 2022: 15 · 2021: 30 · 2020: 22 · 2019: 23 · 2018: 20 · 2017: 24 · 2016: 34 · 2015: 30 · 2014: 19 · 2013: 11
- FWCI
- 21.28
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- British Journal of Clinical Pharmacology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Bristol-Myers Squibb
- Pfizer Inc
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
- Keywords
- apixaban, factor Xa inhibitors, pharmacokinetics, pharmacodynamics, multiple oral doses, dose escalation, safety and tolerability, anticoagulation, international normalized ratio, activated partial thromboplastin time, prothrombin time, steady-state concentration, peak-to-valley ratio, dosing regimen
- MeSH terms
- Administration, Oral, Adult, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Fibrinolytic Agents, Humans, Male, Partial Thromboplastin Time, Prothrombin Time, Pyrazoles, Pyridones, International Normalized Ratio, Young Adult, Factor Xa Inhibitors
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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