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

Overview

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.

Full Title of Study: “A Relative Bioavailability Study of 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2006

Interventions

  • Drug: Donepezil Hydrochloride
    • 10 mg Orally Disintegrating Tablet
  • Drug: Aricept®
    • 10 mg Orally Disintegrating Tablet

Arms, Groups and Cohorts

  • Experimental: Investigational Test Product
    • Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg
  • Active Comparator: Reference Listed Drug
    • Aricept® Orally Disintegrating Tablets, 10 mg

Clinical Trial Outcome Measures

Primary Measures

  • Cmax of Donepezil.
    • Time Frame: Blood samples collected over a 72 hour period.
    • 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.
    • Bioequivalence based on Donepezil AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Teva Pharmaceuticals USA
  • Provider of Information About this Clinical Study
    • Associate Director, Biopharmaceutics, TEVA Pharmaceuticals, USA
  • Overall Official(s)
    • James D Carlson, Pharm.D., Principal Investigator, PRACS Institute, Ltd.

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