Trial reportDrug design, development and therapy2017
Drug-drug interaction of microdose and regular-dose omeprazole with a CYP2C19 inhibitor and inducer.
Trial report in Drug design, development and therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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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
12 citing papers in PubMed.
- Pharmacokinetic Drug-Drug Interaction of Apalutamide, Part 1: Clinical Studies in Healthy Men and Patients with Castration-Resistant Prostate Cancer.Clinical pharmacokinetics · 2020Trial
- Search for Novel Biomarkers to Predict Cytochrome P450 2C19 Activity Using Untargeted Metabolomics of Human Plasma.Metabolites · 2026Article
- Importance and Involvement of Imidazole Structure in Current and Future Therapy.Molecules (Basel, Switzerland) · 2026Review
- Physiologically based pharmacokinetic modeling of fluconazole: interpretation of gender-dependent pharmacokinetics and cytochrome P450 inhibition.Frontiers in pharmacology · 2026Article
- Adequacy of recommendations for adverse event management in national and international treatment guidelines for rifampicin-susceptible tuberculosis: a systematic review.EClinicalMedicine · 2025Review
- The Use of Microdosing for In vivo Phenotyping of Cytochrome P450 Enzymes: Where Do We Stand? A Narrative Review.European journal of drug metabolism and pharmacokinetics · 2024Review
- The application of Phase 0 and microtracer approaches in early clinical development: past, present, and future.Frontiers in pharmacology · 2024Review
- Evaluation of CYP2C19 activity using microdosed oral omeprazole in humans.European journal of clinical pharmacology · 2022Article
- Adapting regulatory drug-drug interaction guidance to design clinical pharmacokinetic natural product-drug interaction studies: A NaPDI Center recommended approach.Clinical and translational science · 2022Review
- Phase 0/microdosing approaches: time for mainstream application in drug development?Nature reviews. Drug discovery · 2020Review
- Application of a microdosed cocktail of 3 oral factor Xa inhibitors to study drug-drug interactions with different perpetrator drugs.British journal of clinical pharmacology · 2020Article
- Predictive Value of Microdose Pharmacokinetics.Clinical pharmacokinetics · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeA microdose drug-drug interaction (DDI) study may be a valuable tool for anticipating drug interaction at therapeutic doses. This study aimed to compare the magnitude of DDIs at microdoses and regular doses to explore the applicability of a microdose DDI study. PATIENTS AND
methodsSix healthy male volunteer subjects were enrolled into each DDI study of omeprazole (victim) and known perpetrators: fluconazole (inhibitor) and rifampin (inducer). For both studies, the microdose (100 μg, cold compound) and the regular dose (20 mg) of omeprazole were given at days 0 and 1, respectively. On days 2-9, the inhibitor or inducer was given daily, and the microdose and regular dose of omeprazole were repeated at days 8 and 9, respectively. Full omeprazole pharmacokinetic samplings were performed at days 0, 1, 8, and 9 of both studies for noncompartmental analysis.
resultsThe magnitude of the DDI, the geometric mean ratios (with perpetrator/omeprazole only) of maximum concentration (C
conclusionOur results may be used as partial evidence that microdose DDI studies may replace regular-dose studies, or at least be used for DDI-screening purposes.
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