Pharmacokinetic Comparisons of Two Donepezil Formulations

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297036
• Other study ID #: 121HPS07D_03
• Status: Completed
• Phase: Phase 1
• First received: February 15, 2011
• Last updated: February 15, 2011
• Start date: January 2008
• Est. completion date: May 2008

Study information

• Verified date: January 2008
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Donepezil, ODT 10 mg
Test- Donepezil Hydrochloride 10 mg Tablet single dose
• Donepezil, 10 mg tablet
Reference: Donepezil Hydrochloride 10 mg Tablet

Locations

Country	Name	City	State
Korea, Republic of	Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Anam Hospital	Chong Kun Dang Pharmaceutical Corp.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	donepezil pharmacokinetics: peak plasma concentrations (Cmax)		240 hours	No
Primary	donepezil pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to 240 hr(AUCall)		240 hours	No
Primary	donepezil pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to infinity(AUCinf)		240 hours	No