Trial reportBritish journal of clinical pharmacology2004
Repeated dosing with donepezil does not affect the safety, tolerability or pharmacokinetics of single-dose thioridazine in young volunteers.
Trial report in British journal of clinical pharmacology, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 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
4 citing papers in PubMed, 10 citations in OpenAlex.
- Dynamic imaging of adaptive stress response pathway activation for prediction of drug induced liver injury.Archives of toxicology · 2018Article
- A systematic and prospectively validated approach for identifying synergistic drug combinations against malaria.Malaria journal · 2018Article
- Whole-Body Distribution of Donepezil as an Acetylcholinesterase Inhibitor after Oral Administration in Normal Human Subjects: AAsia Oceania journal of nuclear medicine & biology · 2017Article
- Donepezil in Alzheimer's disease: From conventional trials to pharmacogenetics.Neuropsychiatric disease and treatment · 2007Article
Corrections and comments
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Authors and funding
5 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo investigate the effects of donepezil at steady state on the safety, tolerability and pharmacokinetics of a single dose of thioridazine, in healthy subjects.
methodsAn open, two-way, balanced crossover study, in 12 subjects (six men and six women) aged 19-41 years. During both treatment periods, subjects received a single oral dose of 50 mg thioridazine; in one period the thioridazine was given alone, and in the other period it was given together with the last of 15 daily, oral doses of donepezil 5 mg. The 'washout' periods were 1 week when thioridazine was given first, and 2 weeks when thioridazine was given last. Plasma concentrations of thioridazine were measured after each dose, and pharmacokinetic parameters were determined. Interactions were tested by using an equivalence analysis in which thioridazine was the 'Reference' and thioridazine + donepezil the 'Test' regimen. Safety and tolerability were monitored.
resultsDonepezil had no marked effect on the pharmacokinetics of thioridazine, as judged by the equivalence analysis of AUC(0-tn), AUC(0-infinity), t((1/2)) and t(max). C(max) was very similar in the 'Test' and 'Reference' regimens, but the confidence intervals were too wide to confirm equivalence. Donepezil was well tolerated, whereas thioridazine was associated with light-headedness, tiredness and postural hypotension, irrespective of whether or not donepezil was given concurrently.
conclusionsRepeated dosing with donepezil, 5 mg daily for 2 weeks, had no significant effect on the safety, tolerability or pharmacokinetics of thioridazine. Thioridazine was poorly tolerated.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.