- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01260948
10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions
January 24, 2011 updated by: Teva Pharmaceuticals USA
A Relative Bioavailability Study of 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions.
This study investigated the relative bioavailability (rate and extend of absorption) of Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai Inc., following a single oral dose (1 x 10 mg orally disintegrating tablet) in healthy adult subjects administered under non-fasting conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
East Grand Forks, Minnesota, United States, 56721
- PRACS Institute, Ltd.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Screening Demographics: All volunteers selected for this study will be healthy men and women 18 years of age or older at the time of dosing. The weight range will not exceed + 20% for height and weight as per Desirable Weights for Adults - 1983 Metropolitan Height and Weight Table.
- Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
If female and:
- of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s); or
- is postmenopausal for at least 1 year; or
- is surgically sterile.
Exclusion Criteria:
- Volunteers with a recent history of drug or alcohol addiction or abuse.
- Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic systems(s) or psychiatric disease (as determined by the clinical investigators).
- Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on reexamination are deemed to be clinically significant.
- Volunteers demonstrating a reactive screen for Hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
- Volunteers demonstrating a positive drug abuse screen when screened for this study.
- Female volunteers demonstrating a positive pregnancy screen.
- Female volunteers who are currently breastfeeding.
- Volunteers with a history of allergic response(s) to donepezil or related drugs.
- Volunteers with a history of clinically significant allergies including drug allergies.
- Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
- Volunteers who currently use tobacco products.
- Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
- Volunteers who report donating greater than 150 mL of blood within 28 days prior to Period I dosing.
- Volunteers who have donated plasma within 14 days of Period I dosing.
- Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing.
- Volunteers who report taking any systemic prescription medication in the 14 days prior to Period I dosing.
- Female volunteers who report the use of oral contraceptives or injectable contraceptives.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Investigational Test Product
Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg
|
10 mg Orally Disintegrating Tablet
|
ACTIVE_COMPARATOR: Reference Listed Drug
Aricept® Orally Disintegrating Tablets, 10 mg
|
10 mg Orally Disintegrating Tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax of Donepezil.
Time Frame: Blood samples collected over a 72 hour period.
|
Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).
|
Blood samples collected over a 72 hour period.
|
AUC0-t of Donepezil.
Time Frame: Blood samples collected over a 72 hour period.
|
Bioequivalence based on Donepezil AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
|
Blood samples collected over a 72 hour period.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (ACTUAL)
May 1, 2006
Study Completion (ACTUAL)
May 1, 2006
Study Registration Dates
First Submitted
December 14, 2010
First Submitted That Met QC Criteria
December 14, 2010
First Posted (ESTIMATE)
December 15, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
February 21, 2011
Last Update Submitted That Met QC Criteria
January 24, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R05-1255
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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