Pharmacokinetics and metabolism of idebenone in healthy male subjects.
PURPOSE: Idebenone 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 m...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 65; no. 5; pp. 493 - 502 |
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| Autores principales: | , , , , |
| Formato: | equations & formulas research tables/charts Journal Article |
| Publicado: |
Springer Nature
May2009
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=105513205&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 105513205 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: May2009 vid: 65 iid: 5 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 105513205 2010261634 10.1007/s00228-008-0596-1 NLM19125241 105513205 ppf: 493 ppct: 9 formats: fmt: @attributes: type: P tig: atl: Pharmacokinetics and metabolism of idebenone in healthy male subjects. aug: au: Bodmer M Vankan P Dreier M Kutz KW Drewe J affil: Department of Clinical Pharmacology, University Hospital Basel, Basel, Switzerland. sug: subj: Quinones Metabolism Quinones Pharmacokinetics Adult Coenzyme Q Metabolism Coenzyme Q Pharmacokinetics Data Analysis Software Descriptive Statistics Friedreich's Ataxia Therapy Male Pharmacy and Pharmacology Quinones Blood Quinones Urine Human Adult: 19-44 years Male ab: PURPOSE: Idebenone 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. METHODS: In 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. RESULTS: Idebenone 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. CONCLUSIONS: Idebenone 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. pubtype: Academic Journal doctype: equations & formulas research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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