10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.

Study Overview
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Brief Summary
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This study investigated the relative bioavailability (rate and extent 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 fasting conditions.

Official Title
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A Relative Bioavailability Study of 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Donepezil Hydrochloride
* Drug: Aricept®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Screening Demographics: All volunteers 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 body frame 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 system(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 the 28 days prior to Period I dosing. Volunteers who have donated plasma within 14 days prior to 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Test Product<br>Donepezil Hydrochloride 10 mg Orally Disintegrating Tablets | Drug: Donepezil Hydrochloride<br>* 10 mg Orally Disintegrating Tablet<br>|
| Active Comparator: Reference Listed Drug<br>Aricept® 10 mg Orally Disintegrating Tablets | Drug: Aricept®<br>* 10 mg Orally Disintegrating Tablet<br>* Other names: Donepezil Hydrochloride (generic name);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Donepezil. | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Healthy Subjects