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

A Relative Bioavailability Study of 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions.

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.

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.