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Pharmacokinetic Comparisons of Two Donepezil Formulations

Information source: Korea University Anam Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer Disease

Intervention: Donepezil, ODT 10 mg (Drug); Donepezil, 10 mg tablet (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Korea University Anam Hospital

Official(s) and/or principal investigator(s):
Ji-Young Park, MD, PhD, Principal Investigator, Affiliation: Anam Hospital, Korea Univeristy College of Medicine


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

donepezil pharmacokinetics: peak plasma concentrations (Cmax)

donepezil pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to 240 hr(AUCall)

donepezil pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to infinity(AUCinf)

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.


Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Male.


Inclusion Criteria:

- Males age 20 to 45 years

- Body weight > 45 kg with +/- 20% of ideal body weight

- Signed and dated informed consent form which meets all criteria of current FDA and

KFDA regulations Exclusion Criteria:

- subjects with acute conditions.

- presence of history affecting ADME

- Clinically significant history or current evidence of a hepatic, renal,

gastrointestinal, or hematologic abnormality

- Hepatitis B, hepatitis C, or HIV infection revealed on the laboratory findings

- Any other acute or chronic disease

- A history of hypersensitivity to donepezil

- A history of alcohol or drug abuse

- Participation in another clinical trial within 3 months

- smoked >10 cigarettes daily

- consumption over 5 glasses daily of beverages containing xanthine derivatives

- use of any medication having the potential to affect the study results within 10 days

before the start of the study.

Locations and Contacts

Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine, Seoul 136-705, Korea, Republic of
Additional Information

Starting date: January 2008
Last updated: February 15, 2011

Page last updated: August 20, 2015

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