10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions

NCT ID: NCT01260948

Last Updated: 2011-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2006-05-31

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Investigational Test Product

Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg

Group Type: EXPERIMENTAL

Donepezil Hydrochloride

Intervention Type: DRUG

10 mg Orally Disintegrating Tablet

Reference Listed Drug

Aricept® Orally Disintegrating Tablets, 10 mg

Group Type: ACTIVE_COMPARATOR

Aricept®

Intervention Type: DRUG

10 mg Orally Disintegrating Tablet

Interventions

Donepezil Hydrochloride

10 mg Orally Disintegrating Tablet

Intervention Type: DRUG

Aricept®

10 mg Orally Disintegrating Tablet

Intervention Type: DRUG

Other Intervention Names

Donepezil Hydrochloride (generic name)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Responsible Party

TEVA Pharmaceuticals, USA

Principal Investigators

James D Carlson, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

PRACS Institute, Ltd.

Locations

PRACS Institute, Ltd.

East Grand Forks, Minnesota, United States

Countries

United States

Other Identifiers

R05-1255

Identifier Type: -

Identifier Source: org_study_id