NCT01297036

Pharmacokinetic Comparisons of Two Donepezil Formulations

Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Donepezil Between Two Donepezil Products, Aricept® Tablet and Neuropezil ODT, in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Korea University Anam Hospital · Academic / Other
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Donepezil, ODT 10 mg	Test- Donepezil Hydrochloride 10 mg Tablet single dose
DRUG	Donepezil, 10 mg tablet	Reference: Donepezil Hydrochloride 10 mg Tablet

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-03-01
• Completion: 2008-05-01
• First posted: 2011-02-16
• Last updated: 2011-02-16

Locations

1 site across 1 country: South Korea