Dokument: Influence of Tiopronin on the Metabolism of Alcohol in Healthy Subjects
| Titel: | Influence of Tiopronin on the Metabolism of Alcohol in Healthy Subjects | |||||||
| URL für Lesezeichen: | https://docserv.uni-duesseldorf.de/servlets/DocumentServlet?id=45859 | |||||||
| URN (NBN): | urn:nbn:de:hbz:061-20180502-132556-6 | |||||||
| Kollektion: | Dissertationen | |||||||
| Sprache: | Englisch | |||||||
| Dokumententyp: | Wissenschaftliche Abschlussarbeiten » Dissertation | |||||||
| Medientyp: | Text | |||||||
| Autor: | Nass, Friederike [Autor] | |||||||
| Dateien: |
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| Stichwörter: | Tiopronin, Alcohol, Cystinuria | |||||||
| Dewey Dezimal-Klassifikation: | 600 Technik, Medizin, angewandte Wissenschaften » 610 Medizin und Gesundheit | |||||||
| Beschreibung: | Background: Many drug safety- and drug-alcohol interaction studies have been done for frequently used medications or drugs with high financial interests. Orphan drugs like tiopronin – a drug which is used in the treatment of the rare disease cystinuria - are often neglected in terms of clinical research. We analysed the interaction of tiopronin on the metabolism of alcohol and the medication’s safety in this combination in healthy volunteers.
Methods: In this investigator-driven randomised, double blind, cross-over study, 13 healthy subjects received the medication (500 mg tiopronin or an identical looking placebo) one hour before the intake of 0.8 g alcohol per kg bodyweight. The two study days, in which each participant received each treatment once, were one week apart. For the primary objective blood alcohol concentrations were measured 0 h (before intake of alcohol, after intake of study drug), 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h and 12 h after the consumption of alcohol. Primary objectives AUC and elimination rate k were analysed based on a mixed linear model with mixed treatment-effect, fixed period-effect and fixed interaction term. Secondary objectives such as Cmax, tmax values of alcohol metabolism, acetaldehyde blood levels, concentration abilities and the drug’s safety profile were determined with similar analysis and descriptive statistics. Results: There was no significant treatment effect for either of the objectives. Significant differences in periods could be found in concentration tests and seem to be based on learning effects. No serious adverse event (SAE) occurred. All adverse event were reversible and similarly distributed among none treatment and treatment. Conclusion: It was shown that tiopronin does not affect the metabolism of alcohol. There were no SAE when combining tiopronin and alcohol in healthy subjects | |||||||
| Lizenz: |  Urheberrechtsschutz | |||||||
| Fachbereich / Einrichtung: | Medizinische Fakultät | |||||||
| Dokument erstellt am: | 02.05.2018 | |||||||
| Dateien geändert am: | 02.05.2018 | |||||||
| Promotionsantrag am: | 23.06.2017 | |||||||
| Datum der Promotion: | 23.06.2017 |
