10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.
Condition: Healthy
Intervention: Donepezil Hydrochloride; Aricept®
Intervention description: 10 mg Orally Disintegrating Tablet; 10 mg Orally Disintegrating Tablet
Intervention MeSH terms: Donepezil
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

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.
    

Eligibility 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.