A Phase 1 interventional study of Donepezil, ODT 10 mg and Donepezil, 10 mg tablet in Alzheimer Disease, sponsored by Korea University Anam Hospital. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-02-16.
Sponsored by Korea University Anam Hospital · Phase 1 and Interventional
To compare the relative bioavailability and pharmacokinetic characteristics of a newly developed donepezil formulation with a conventional formulation in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.
This single dose, open label, balanced, randomized, two-treatment, two-period, two-sequence, crossover study was conducted to compare the relative bioavailability and pharmacokinetic characteristics of a newly developed formulation with a conventional formulation in healthy subjects.
For this, a single-center, randomized, single-dose, open-label, 2-way crossover study with a 21-day washout period was conducted in 22 healthy volunteers. Plasma samples for the analysis of donepezil were collected up to 240 h after drug administration. Participants received either reference or test drug formulation of 10 mg donepezil in the first period and the alternative formulation in the second period. Plasma concentrations of donepezil were determined by validated high-performance liquid chromatography coupled to tandem mass spectrometry detection. Pharmacokinetic parameters, including Cmax and AUC, were determined by noncompartmental analysis. Analysis of variance (ANOVA) was carried out using log-transformed Cmax and AUC, and the mean ratios and their 90% confidence intervals (CI) were calculated. According to regulatory requirements set forth by Korea and the US Food and Drug Administration, products meet the criteria for bioequivalence if the 90% CIs of the mean ratios for Cmax and AUC are within the range of 0.80 to 1.25.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 22 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
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Exclusion Criteria:
Treated with Reference (Aricept, 10 mg donepezil tablet)
Drug: Donepezil, 10 mg tablet
Treated with Test (Neuropezil, 10 donepezil ODT, orally disintegrating tablet)
Drug: Donepezil, ODT 10 mg
Test- Donepezil Hydrochloride 10 mg Tablet single dose
Also known as: Neuropezil ODS, developed by Chong Kun Dang Co, Ltd.
Reference: Donepezil Hydrochloride 10 mg Tablet
Also known as: Aricept:, Manufactured by Dae Woong harm. Co. Ltd, Seoul, Korea
donepezil pharmacokinetics: peak plasma concentrations (Cmax)
Time frame: 240 hours
donepezil pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to 240 hr(AUCall)
Time frame: 240 hours
donepezil pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to infinity(AUCinf)
Time frame: 240 hours
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
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Korea University Anam Hospital