Expired Study
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East Grand Forks, Minnesota 56721


Purpose:

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.


Criteria:

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.


NCT ID:

NCT01260948


Primary Contact:

Principal Investigator
James D Carlson, Pharm.D.
PRACS Institute, Ltd.


Backup Contact:

N/A


Location Contact:

East Grand Forks, Minnesota 56721
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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