Overview

10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.

Status:
Completed
Trial end date:
2006-05-01
Target enrollment:
0
Participant gender:
All
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 AriceptĀ® 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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Teva Pharmaceuticals USA
Treatments:
Donepezil
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.