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

Teva Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Aricept®; Drug: Donepezil Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01260948

R05-1255

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

26 participants in 2 patient groups

Investigational Test Product

Experimental group

Description:

Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg

Treatment:

Drug: Donepezil Hydrochloride

Reference Listed Drug

Active Comparator group

Description:

Aricept® Orally Disintegrating Tablets, 10 mg

Treatment:

Drug: Aricept®