Clinical trial NCT01260922: 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.
Official title: A Relative Bioavailability Study of 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Healthy Subjects
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2010-12-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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.

Primary outcomes:
measure: Cmax of Donepezil.
timeFrame: Blood samples collected over a 72 hour period.
measure: AUC0-t of Donepezil.
timeFrame: Blood samples collected over a 72 hour period.
Secondary outcomes:
Other outcomes:
Locations:
city: East Grand Forks
country: United States
facility: PRACS Institute, Ltd.
state: Minnesota
Study officials:
affiliation: PRACS Institute, Ltd.
name: James D Carlson, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: