Trial reportBritish journal of clinical pharmacology2013
A semi-mechanistic absorption model to evaluate drug-drug interaction with dabigatran: application with clarithromycin.
Trial report in British journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
31 citing papers in PubMed, 69 citations in OpenAlex.
- Differential Influence of the Antiretroviral Pharmacokinetic Enhancers Ritonavir and Cobicistat on Intestinal P-Glycoprotein Transport and the Pharmacokinetic/Pharmacodynamic Disposition of Dabigatran.Antimicrobial agents and chemotherapy · 2017Trial
- Deciphering the Relative Contribution of CYP3A4 Versus P-Glycoprotein for the Shared Substrate Cyclosporine-Commentary on Lown et al.Clinical pharmacology and therapeutics · 2025Article
- Evaluation of Drug-Drug Interactions Between Clarithromycin and Direct Oral Anticoagulants Using Physiologically Based Pharmacokinetic Models.Pharmaceutics · 2024Article
- Assessing the relative contribution of CYP3A-and P-gp-mediated pathways to the overall disposition and drug-drug interaction of dabigatran etexilate using a comprehensive mechanistic physiological-based pharmacokinetic model.Frontiers in pharmacology · 2024Article
- Clinical significance of the rivaroxaban-dronedarone interaction: insights from physiologically based pharmacokinetic modelling.European heart journal open · 2023Review
- Analysis of Complex Absorption After Multiple Dosing: Application to the Interaction Between the P-glycoprotein Substrate Talinolol and Rifampicin.Pharmaceutical research · 2022Article
- DOAC drug interactions management resource.Canadian pharmacists journal : CPJ = Revue des pharmaciens du Canada : RPC · 2022Article
- Drug-Drug Interaction Surveillance Study: Comparing Self-Controlled Designs in Five Empirical Examples in Real-World Data.Clinical pharmacology and therapeutics · 2021Article
- Physiologically-based pharmacokinetics modeling to investigate formulation factors influencing the generic substitution of dabigatran etexilate.CPT: pharmacometrics & systems pharmacology · 2021Article
- Pharmacokinetic-Pharmacodynamic Modeling of Tumor Targeted Drug Delivery Using Nano-Engineered Mesenchymal Stem Cells.Pharmaceutics · 2021Article
- Drug interactions of direct oral anticoagulants in elderly patients with cardiometabolic diseases.Current research in pharmacology and drug discovery · 2021Review
- Prediction of potential drug interactions between repurposed COVID-19 and antitubercular drugs: an integrational approach of drug information software and computational techniques data.Therapeutic advances in drug safety · 2021Article
- Risk of Hospitalization With Hemorrhage Among Older Adults Taking Clarithromycin vs Azithromycin and Direct Oral Anticoagulants.JAMA internal medicine · 2020Article
- Drug-Drug Interactions with Direct Oral Anticoagulants.Clinical pharmacokinetics · 2020Review
- Binding Site Interactions of Modulators of Breast Cancer Resistance Protein, Multidrug Resistance-Associated Protein 2, and P-Glycoprotein Activity.Molecular pharmaceutics · 2020Article
- Predicted effect of ticagrelor on the pharmacokinetics of dabigatran etexilate using physiologically based pharmacokinetic modeling.Scientific reports · 2020Article
- A Comprehensive Whole-Body Physiologically Based Pharmacokinetic Model of Dabigatran Etexilate, Dabigatran and Dabigatran Glucuronide in Healthy Adults and Renally Impaired Patients.Clinical pharmacokinetics · 2019Article
- Clinical Management of Pharmacokinetic Drug Interactions with Direct Oral Anticoagulants (DOACs).Drugs · 2019Review
- A Generic Model for Quantitative Prediction of Interactions Mediated by Efflux Transporters and Cytochromes: Application to P-Glycoprotein and Cytochrome 3A4.Clinical pharmacokinetics · 2019Article
- The Significance of Drug-Drug and Drug-Food Interactions of Oral Anticoagulation.Arrhythmia & electrophysiology review · 2018Article
Corrections and comments
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Authors and funding
9 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimThe aim of this study was to develop a PK/PD model to assess drug-drug interactions between dabigatran and P-gp modulators, using the example of clarithromycin, a strong inhibitor of P-gp.
methodsTen healthy male volunteers were randomized to receive in the first treatment period a single 300 mg dose of dabigatran etexilate (DE) and in the second treatment period 500 mg clarithromycin twice daily during 3 days and then 300 mg DE plus 500 mg clarithromycin on the fourth day, or the same treatments in the reverse sequence. Dabigatran plasma concentration and ecarin clotting time (ECT) were measured on 11 blood samples. Models were built using a non-linear mixed effect modelling approach.
resultsThe best PK model was based on an inverse Gaussian absorption process with two compartments. The relationship between dabigatran concentration and ECT was implemented as a linear function. No continuous covariate was associated with a significant decrease in the objective function. The concomitant administration of clarithromycin induced a significant change only in DE bioavailability, which increased from 6.5% to 10.1% in the presence of clarithromycin. Clarithromycin increased peak concentration and AUC by 60.2% and 49.1% respectively.
conclusionThe model proposed effectively describes the complex PK of dabigatran and takes into account drug-drug interactions with P-gp activity modulators, such as clarithromycin.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.