Bioavailability Study of Donepezil Hydrochloride Tablets 23 mg Under Fed Condition

August 13, 2013 updated by: Dr. Reddy's Laboratories Limited

Single Dose Crossover Comparative Bioavailability Study of Donepezil 23 mg Tablets in Healthy Male and Female Volunteers / Fed State

To evaluate and compare the relative bioavailability and therefore the bioequivalence of two different formulations of donepezil after a single oral dose administration under fed conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover study under fed conditions.

Study Type

Interventional

Enrollment (Actual)

94

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
      • Mount Royal, Quebec, Canada, H3P 3P1
        • Algorithme Pharma Inc.

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

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female volunteer
  2. Volunteer aged of at least 18 years but not older than 45 years
  3. Volunteer with a body mass index (BMI) greater than or equal to 21 and below 30 kg/m2
  4. Volunteer with a body weight greater than or equal to 60 kg.
  5. Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes or less per day for at least 3 months before day 1 of this study. An ex-smoker is defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.
  6. Availability for the entire study period
  7. Motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the physician or designee.
  8. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
  9. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis)
  10. Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer

Exclusion Criteria

  1. Seated pulse rate less than 50 bpm at screening
  2. Seated blood pressure below 105/60 mmHg at screening
  3. Seated blood pressure below 105/60 mmHg before drug administration
  4. Females who are pregnant or are lactating
  5. Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study
  6. History of significant hypersensitivity to donepezil, piperidine derivatives, scopolamine, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
  7. Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
  8. History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
  9. Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
  10. Suicidal tendency, history of or disposition to seizures, state of confusion,clinically relevant psychiatric diseases
  11. Presence of out-of-range cardiac interval (PR < 110 msec, PR > 200 msec, QRS >110 msec and QTc > 440 msec) on the screening ECG or other clinically significant ECG abnormalities.
  12. Use of ASA or NSAIDs (or any product containing ASA or NSAIDs) in the previous 7 days before day 1 of this study
  13. Use of diphenhydramine in the previous 10 hours before day 1 of this study
  14. Known presence of rare hereditary problems of galactose and /or lactose intolerance
  15. Known presence of glaucoma or a predisposition to angle-closure glaucoma
  16. Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
  17. Any clinically significant illness in the previous 28 days before day 1 of this study
  18. Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 28 days before day 1 of this study
  19. Any history of tuberculosis and/or prophylaxis for tuberculosis
  20. Positive urine screening of alcohol and/or drugs of abuse
  21. Positive results to HIV, HBsAg or anti-HCV tests
  22. Females who are pregnant according to a positive serum pregnancy test
  23. Volunteers who took an Investigational Product (in another clinical trial) or donated 50 mL or more of blood in the previous 28 days before day 1 of this study.
  24. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Donepezil Hydrochloride Tablets, 23 mg
Donepezil Hydrochloride Tablets, 23 mg of Dr.Reddy's Laboratories Ltd
Donepezil Hydrochloride tablets,23 mg
Other Names:
  • Aricept
ACTIVE_COMPARATOR: Aricept
Aricept® 23 mg tablet of Eisai Inc
Donepezil Hydrochloride tablets,23 mg
Other Names:
  • Aricept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under curve (AUC)
Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18, 24, 48 and 72 hours
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18, 24, 48 and 72 hours

Collaborators and Investigators

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

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

October 1, 2010

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

August 13, 2013

First Submitted That Met QC Criteria

August 13, 2013

First Posted (ESTIMATE)

August 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 13, 2013

Last Verified

February 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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