Pharmacokinetic Comparisons of Two Donepezil Formulations
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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 |
- 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:
|
|
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:
|
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 |
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| Korea, Republic of | |
| Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine | |
| Seoul, Korea, Republic of, 136-705 | |
| 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 Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil |
Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013