Pharmacokinetic Comparisons of Two Donepezil Formulations

This study has been completed.
Sponsor:
Collaborator:
ChongKeunDang Co., Ltd.
Information provided by:
Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT01297036
First received: February 15, 2011
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
Drug: Donepezil, ODT 10 mg
Drug: Donepezil, 10 mg tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Korea University Anam Hospital:

Primary Outcome Measures:
  • donepezil pharmacokinetics: peak plasma concentrations (Cmax) [ Time Frame: 240 hours ] [ Designated as safety issue: No ]
  • donepezil pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to 240 hr(AUCall) [ Time Frame: 240 hours ] [ Designated as safety issue: No ]
  • donepezil pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to infinity(AUCinf) [ Time Frame: 240 hours ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: January 2008
Study Completion Date: May 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01297036

Locations
Korea, Republic of
Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine
Seoul, Korea, Republic of, 136-705
Sponsors and Collaborators
Korea University Anam Hospital
ChongKeunDang Co., Ltd.
Investigators
Principal Investigator: Ji-Young Park, MD, PhD Anam Hospital, Korea Univeristy College of Medicine
  More Information

No publications provided by Korea University Anam Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ji-Young Park, MD/Associate Professor of Clinical Pharmacology, Anam Hospital, Dept. of Clincial Pharmacology, Anam Hospital, Korea University College of Medicine, Seoul, Korea
ClinicalTrials.gov Identifier: NCT01297036     History of Changes
Other Study ID Numbers: 121HPS07D_03
Study First Received: February 15, 2011
Last Updated: February 15, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea University Anam Hospital:
Pharmacokinetics
Bioequivalence
Donepezil

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Donepezil
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014