10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01260922
First received: December 14, 2010
Last updated: January 24, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Donepezil Hydrochloride
Drug: Aricept®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Official Title: A Relative Bioavailability Study of 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax of Donepezil. [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).

  • AUC0-t of Donepezil. [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Donepezil AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).


Enrollment: 26
Study Start Date: April 2006
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Test Product
Donepezil Hydrochloride 10 mg Orally Disintegrating Tablets
Drug: Donepezil Hydrochloride
10 mg Orally Disintegrating Tablet
Active Comparator: Reference Listed Drug
Aricept® 10 mg Orally Disintegrating Tablets
Drug: Aricept®
10 mg Orally Disintegrating Tablet
Other Name: Donepezil Hydrochloride (generic name)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260922

Locations
United States, Minnesota
PRACS Institute, Ltd.
East Grand Forks, Minnesota, United States, 56721
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: James D Carlson, Pharm.D. PRACS Institute, Ltd.
  More Information

No publications provided

Responsible Party: Associate Director, Biopharmaceutics, TEVA Pharmaceuticals, USA
ClinicalTrials.gov Identifier: NCT01260922     History of Changes
Other Study ID Numbers: R05-1254
Study First Received: December 14, 2010
Results First Received: January 24, 2011
Last Updated: January 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Donepezil
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014