10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.

NCT01260922 | Completed Phase 1 Results

• 1 other identifier: R05-1254
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Investigational Test Product

EXPERIMENTAL

Donepezil Hydrochloride 10 mg Orally Disintegrating Tablets

Drug: Donepezil Hydrochloride

Reference Listed Drug

ACTIVE COMPARATOR

Aricept® 10 mg Orally Disintegrating Tablets

Drug: Aricept®

Interventions

Donepezil Hydrochloride DRUG

10 mg Orally Disintegrating Tablet

Investigational Test Product

Aricept® DRUG

10 mg Orally Disintegrating Tablet

Also known as: Donepezil Hydrochloride (generic name)

Reference Listed Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

PRACS Institute, Ltd.

East Grand Forks, Minnesota, 56721, United States

Location

MeSH Terms

Interventions

Donepezil

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Associate Director, Biopharmaceutics
• Organization: Teva Pharmaceuticals, USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• James D Carlson, Pharm.D.

  PRACS Institute, Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 15, 2010
• Study Start: April 1, 2006
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: February 21, 2011
• Results First Posted: February 21, 2011

Record last verified: 2011-01

Locations

US (1)