Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioavailability Study of Donepezil Hydrochloride Tablets 23 mg Under Fed Condition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01923259
Recruitment Status : Completed
First Posted : August 15, 2013
Last Update Posted : August 15, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE August 13, 2013
First Posted Date  ICMJE August 15, 2013
Last Update Posted Date August 15, 2013
Study Start Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability Study of Donepezil Hydrochloride Tablets 23 mg Under Fed Condition
Official Title  ICMJE Single Dose Crossover Comparative Bioavailability Study of Donepezil 23 mg Tablets in Healthy Male and Female Volunteers / Fed State
Brief Summary 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.
Detailed Description Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover study under fed conditions.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Donepezil
Donepezil Hydrochloride tablets,23 mg
Other Name: Aricept
Study Arms  ICMJE
  • Experimental: Donepezil Hydrochloride Tablets, 23 mg
    Donepezil Hydrochloride Tablets, 23 mg of Dr.Reddy's Laboratories Ltd
    Intervention: Drug: Donepezil
  • Active Comparator: Aricept
    Aricept® 23 mg tablet of Eisai Inc
    Intervention: Drug: Donepezil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2013)
94
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01923259
Other Study ID Numbers  ICMJE DNI-P0-653
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Sicard, MD Algorithme Pharma Inc
PRS Account Dr. Reddy's Laboratories Limited
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP