10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01260922

Run by

Teva Pharmaceuticals USA

People needed

26

Starts

2006-04-01

Expected to finish

2006-05-01

Last updated by the study team

2011-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• PRACS Institute, Ltd. — East Grand Forks, Minnesota, United States

Full record on ClinicalTrials.gov

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