Pharmacokinetic Comparisons of Two Donepezil Formulations

February 15, 2011 updated by: Korea University Anam Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Reference arm
Treated with Reference (Aricept, 10 mg donepezil tablet)
Drug: Donepezil, 10 mg tablet
Reference: Donepezil Hydrochloride 10 mg Tablet
Other Names:
  • Aricept:
  • Manufactured by Dae Woong harm. Co. Ltd, Seoul, Korea
Experimental: Test arm
Treated with Test (Neuropezil, 10 donepezil ODT, orally disintegrating tablet)
Drug: Donepezil, ODT 10 mg
Test- Donepezil Hydrochloride 10 mg Tablet single dose
Other Names:
  • Neuropezil ODS
  • developed by Chong Kun Dang Co, Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
donepezil pharmacokinetics: peak plasma concentrations (Cmax)
Time Frame: 240 hours
240 hours
donepezil pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to 240 hr(AUCall)
Time Frame: 240 hours
240 hours
donepezil pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to infinity(AUCinf)
Time Frame: 240 hours
240 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Collaborators

Chong Kun Dang Pharmaceutical Corp.

Investigators

  • Principal Investigator: Ji-Young Park, MD, PhD, Anam Hospital, Korea Univeristy College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

February 15, 2011

First Submitted That Met QC Criteria

February 15, 2011

First Posted (Estimate)

February 16, 2011

Study Record Updates

Last Update Posted (Estimate)

February 16, 2011

Last Update Submitted That Met QC Criteria

February 15, 2011

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121HPS07D_03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease

Clinical Trials on Donepezil, 10 mg tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe