Pharmacokinetic Comparisons of Two Donepezil Formulations

NCT ID: NCT01297036

Last Updated: 2011-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Reference arm

Treated with Reference (Aricept, 10 mg donepezil tablet)

Group Type: ACTIVE_COMPARATOR

Donepezil, 10 mg tablet

Intervention Type: DRUG

Reference: Donepezil Hydrochloride 10 mg Tablet

Test arm

Treated with Test (Neuropezil, 10 donepezil ODT, orally disintegrating tablet)

Group Type: EXPERIMENTAL

Donepezil, ODT 10 mg

Intervention Type: DRUG

Test- Donepezil Hydrochloride 10 mg Tablet single dose

Interventions

Donepezil, ODT 10 mg

Test- Donepezil Hydrochloride 10 mg Tablet single dose

Intervention Type: DRUG

Donepezil, 10 mg tablet

Reference: Donepezil Hydrochloride 10 mg Tablet

Intervention Type: DRUG

Other Intervention Names

Neuropezil ODS; developed by Chong Kun Dang Co, Ltd.; Aricept: Manufactured by Dae Woong harm. Co. Ltd, Seoul, Korea

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical Corp.

INDUSTRY

Sponsor Role: collaborator

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dept. of Clincial Pharmacology, Anam Hospital, Korea University College of Medicine, Seoul, Korea

Principal Investigators

Ji-Young Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Anam Hospital, Korea Univeristy College of Medicine

Locations

Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine

Seoul, Seoul, South Korea

Countries

South Korea

References

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. doi: 10.1016/j.clinthera.2011.06.003. Epub 2011 Jul 2.

Reference Type: DERIVED

PMID: 21723605 (View on PubMed)

Other Identifiers

121HPS07D_03

Identifier Type: -

Identifier Source: org_study_id