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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

February 15, 2011
February 15, 2011
January 2008
March 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Alzheimer Disease
  • Drug: Donepezil, ODT 10 mg
    Test- Donepezil Hydrochloride 10 mg Tablet single dose
    Other Names:
    • Neuropezil ODS
    • developed by Chong Kun Dang Co, Ltd.
  • Drug: Donepezil, 10 mg tablet
    Reference: Donepezil Hydrochloride 10 mg Tablet
    Other Names:
    • Aricept:
    • Manufactured by Dae Woong harm. Co. Ltd, Seoul, Korea
  • Active Comparator: Reference arm
    Treated with Reference (Aricept, 10 mg donepezil tablet)
    Intervention: Drug: Donepezil, 10 mg tablet
  • Experimental: Test arm
    Treated with Test (Neuropezil, 10 donepezil ODT, orally disintegrating tablet)
    Intervention: Drug: Donepezil, ODT 10 mg
Kim KA, Lim JL, Kim C, Park JY. Pharmacokinetic comparison of orally disintegrating and conventional donepezil formulations in healthy Korean male subjects: a single-dose, randomized, open-label, 2-sequence, 2-period crossover study. Clin Ther. 2011 Jul;33(7):965-72. Epub 2011 Jul 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
May 2008
March 2008   (final data collection date for primary outcome measure)

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.
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01297036
121HPS07D_03
No
Ji-Young Park, MD/Associate Professor of Clinical Pharmacology, Anam Hospital, Dept. of Clincial Pharmacology, Anam Hospital, Korea University College of Medicine, Seoul, Korea
Korea University Anam Hospital
ChongKeunDang Co., Ltd.
Principal Investigator: Ji-Young Park, MD, PhD Anam Hospital, Korea Univeristy College of Medicine
Korea University Anam Hospital
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP