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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

December 14, 2010
January 24, 2011
April 2006
May 2006   (final data collection date for primary outcome measure)
  • 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).
Same as current
Complete list of historical versions of study NCT01260922 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.
A Relative Bioavailability Study of 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Healthy
  • Drug: Donepezil Hydrochloride
    10 mg Orally Disintegrating Tablet
  • Drug: Aricept®
    10 mg Orally Disintegrating Tablet
    Other Name: Donepezil Hydrochloride (generic name)
  • Experimental: Investigational Test Product
    Donepezil Hydrochloride 10 mg Orally Disintegrating Tablets
    Intervention: Drug: Donepezil Hydrochloride
  • Active Comparator: Reference Listed Drug
    Aricept® 10 mg Orally Disintegrating Tablets
    Intervention: Drug: Aricept®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
May 2006
May 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01260922
R05-1254
No
Associate Director, Biopharmaceutics, TEVA Pharmaceuticals, USA
Teva Pharmaceuticals USA
Not Provided
Principal Investigator: James D Carlson, Pharm.D. PRACS Institute, Ltd.
Teva Pharmaceuticals USA
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP