Trial reportDrug design, development and therapy2021
Multiple Administrations of Itraconazole Increase Plasma Exposure to Pyrotinib in Chinese Healthy Adults.
Trial report in Drug design, development and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed.
- Advances in the study of pyrotinib for the treatment of HER2-positive breast cancer.Breast cancer research : BCR · 2026Review
- Prediction of Pharmacokinetic Drug-Drug Interactions Involving Anlotinib as a Victim by Using Physiologically Based Pharmacokinetic Modeling.Drug design, development and therapy · 2024Article
- Pyrotinib as a therapeutic for HER2-positive breast cancer.Translational cancer research · 2023Article
- Pyrotinib combining with radiotherapy on breast cancer with brain metastasis.Experimental biology and medicine (Maywood, N.J.) · 2023Article
- Pyrotinib-associated acute kidney injury: A case report.Cancer innovation · 2022Article
- Pyrotinib-based treatments in HER2-positive breast cancer patients with brain metastases.Annals of medicine · 2022Article
- Involvement of Transporters in Intestinal Drug-Drug Interactions of Oral Targeted Anticancer Drugs Assessed by Changes in Drug Absorption Time.Pharmaceutics · 2022Article
- Differential effects of ketoconazole, fluconazole, and itraconazole on the pharmacokinetics of pyrotinibFrontiers in pharmacology · 2022Article
- Prediction of pyrotinib exposure based on physiologically-based pharmacokinetic model and endogenous biomarker.Frontiers in pharmacology · 2022Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposePyrotinib, an irreversible human epidermal growth factor receptor 2 (HER2), is a epidermal growth factor receptor double-target tyrosine kinase inhibitor used for treating HER2-positive breast cancer. This study aimed to evaluate the impact of the strong CYP3A4 inhibitor itraconazole on the safety and pharmacokinetics of pyrotinib in Chinese healthy adults. PATIENTS AND
methodsThis was an open-label, randomized, self-control study. Eighteen healthy adults were included in this trial. They received a single 80 mg dose of pyrotinib orally on days 1 and 9, and a 200 mg once-daily dose of itraconazole on days 6 through 22. Blood samples were obtained, and the drug concentration was detected using liquid chromatography/tandem mass spectrometry.
resultsCompared with pyrotinib alone, the exposure to pyrotinib co-administered with itraconazole substantially increased, and the
conclusionThe exposure to pyrotinib was substantially affected by the action of itraconazole. The concomitant use of pyrotinib with itraconazole might require dose modification of pyrotinib. All treatments were well tolerated in healthy participants. CLINICAL TRIAL REGISTRY: http://www.chinadrugtrials.org.cn/clinicaltrials.prosearch.dhtml, CTR20191866.
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