Donepezil 10 mg Tablets Under Fasting Conditions

September 20, 2011 updated by: Teva Pharmaceuticals USA

Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Donepezil 10 mg Tablet and Aricept® (Reference) Following a 10 mg Dose in Healthy Subjects Under Fasting Conditions

The objective of this study was to compare the rate and extent of absorption of donepezil 10 mg tablet (test) versus Aricept® (reference), administered as a 1 x 10 mg tablet under fasting conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Montreal, Quebec, Canada, H3X 2H9
        • Anapharm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, non-smoker, > 18 and < 55 years of age.
  • Capable of consent.
  • BMI > 19.0 and < 27.0.
  • Good state of health (no clinically significant deviations from normal clinical results and laboratory test findings.

Exclusion Criteria:

  • Absence of any inclusion criteria.
  • Clinically significant illnesses (including hyperglycemia, any form of diabetes or glucose intolerance, congestive heart failure, hepatitis, hypotensive episodes) or surgery within 8 weeks prior to dosing.
  • Any clinically significant abnormality or abnormal laboratory test results found during medical screening.
  • Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
  • Positive test for hepatitis B, hepatitis C, or HIV at screening.
  • ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 95 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
  • History of significant alcohol abuse or drug abuse within one year prior to screening visit.
  • Regular use of alcohol within 12 months prior to the screening visit (more than 14 units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]), or positive alcohol breath test as screening.
  • Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine, and crack) within 1 year prior to the screening visit or positive drug screen at screening.
  • History of allergic reactions to donepezil, piperidine derivatives, or other related drugs.
  • Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants, cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
  • Use of an investigational drug or participation in an investigational study within 30 days prior to dosing.
  • Clinically significant history or presence of any gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
  • Any clinically significant history or presence of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, or metabolic disease.
  • Use of prescription medication within 14 days prior to the administration of study medication of over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of the study medication, except for topical products without systemic absorption and hormonal contraceptives.
  • Difficulty to swallow study medication.
  • Use of any tobacco products in the 3 months preceding the screening visit.
  • Any food allergy, intolerance, restriction, or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in this study.
  • A depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to administration of the study medication.
  • Donation of plasma (500 mL) within 7 days prior to drug administration. Donation of loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to the administration of the study medication as follows: 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56 days prior to drug administration.
  • Positive urine pregnancy test at screening.
  • Breast-feeding subject.
  • Female subjects of childbearing potential having unprotected sexual intercourse with any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for at least 6 months) within 14 days prior to study drug administration.
  • History of asthma or obstructive pulmonary disease.
  • History of ulcer disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational Test Product
Donepezil 10 mg Tablets
10 mg Tablet
Active Comparator: Reference Listed Drug
Aricept® 10 mg Tablets
10 mg Tablet
Other Names:
  • Donepezil (generic name)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax of Donepezil.
Time Frame: Blood samples collected over a 72 hour period.
Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).
Blood samples collected over a 72 hour period.
AUC0-72 of Donepezil.
Time Frame: Blood samples collected over a 72 hour period.
Bioequivalence based on Donepezil AUC0-72 (area under the concentration-time curve from time zero to time of last measurable concentration).
Blood samples collected over a 72 hour period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Benoit J Deschamps, M.D., Anapharm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

September 20, 2011

First Posted (Estimate)

September 23, 2011

Study Record Updates

Last Update Posted (Estimate)

September 23, 2011

Last Update Submitted That Met QC Criteria

September 20, 2011

Last Verified

September 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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