Trial reportEuropean journal of clinical pharmacology2009
Pharmacokinetics and metabolism of idebenone in healthy male subjects.
Trial report in European journal of clinical pharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
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
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.
- Nanotechnology-based drug delivery systems for the treatment of Alzheimer's disease.International journal of nanomedicine · 2015Pooled it
- Linking Heat Shock Protein 70 and Parkin in Parkinson's Disease.Molecular neurobiology · 2023Review
- Amphiphilic Cyclodextrin Nanoparticles as Delivery System for Idebenone: A Preformulation Study.Molecules (Basel, Switzerland) · 2023Article
- Chitosan/Cyclodextrin Nanospheres for Potential Nose-to-Brain Targeting of Idebenone.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Shc inhibitor idebenone ameliorates liver injury and fibrosis in dietary NASH in mice.Journal of biochemical and molecular toxicology · 2021Article
- Bioactivity Profiles of Cytoprotective Short-Chain Quinones.Molecules (Basel, Switzerland) · 2021Article
- Coenzyme QAntioxidants (Basel, Switzerland) · 2021Review
- Comparative In Vitro Toxicology of Novel Cytoprotective Short-Chain Naphthoquinones.Pharmaceuticals (Basel, Switzerland) · 2020Article
- Metabolic Stability of New Mito-Protective Short-Chain Naphthoquinones.Pharmaceuticals (Basel, Switzerland) · 2020Article
- Physicochemical Characterization and Antioxidant Activity Evaluation of Idebenone/Hydroxypropyl-Biomolecules · 2019Article
- Review
- Article
- Inhibition of ANO1/TMEM16A Chloride Channel by Idebenone and Its Cytotoxicity to Cancer Cell Lines.PloS one · 2015Article
- The effects of idebenone on mitochondrial bioenergetics.Biochimica et biophysica acta · 2012Article
- Current and emerging treatment options in the management of Friedreich ataxia.Neuropsychiatric disease and treatment · 2010Article
- Pharmacokinetic properties and metabolism of idebenone.Journal of neurology · 2009Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeIdebenone is a synthetic analogue of ubiquinone that may be beneficial in the treatment of Friedreich's ataxia. Since in previous pharmacokinetic trials only lower doses were studied, it was the aim of this study to evaluate the pharmacokinetics of idebenone in higher doses of up to 2,250 mg/day.
methodsIn this open, randomized trial, 25 healthy male subjects received first either a single oral dose of 150 mg or 750 mg of idebenone, then the same dose given at 8-h intervals for 14 days.
resultsIdebenone and its metabolites appeared in the plasma quickly. Over 99% of parent idebenone was metabolized, indicating a high first-pass effect. C(max) and AUC(0-t) values for parent idebenone and its metabolites increased in a dose-proportional manner. There was virtually no accumulation of parent drug or metabolites following multiple dosing.
conclusionsIdebenone exhibited dose-dependent pharmacokinetics in daily doses up to 2,250 mg. In 6/14 subjects, adverse events of mild to moderate severity were observed.
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Registered trials
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