Donepezil 10 mg Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01439243
First received: September 20, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

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 1 x 10 mg tablet under fed conditions.


Condition Intervention Phase
Healthy
Drug: Donepezil
Drug: Aricept®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Donepezil (Test) 10 mg Tablet and Aricept® (Reference) Following a 10 mg Dose in Healthy Subjects Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax of Donepezil. [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).

  • AUC0-72 of Donepezil. [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Donepezil AUC0-72 (area under the concentration-time curve from time zero to time of last measurable concentration).


Enrollment: 26
Study Start Date: June 2007
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Test Product
Donepezil 10 mg Tablets
Drug: Donepezil
10 mg Tablet
Active Comparator: Reference Listed Drug
Aricept® 10 mg Tablets
Drug: Aricept®
10 mg Tablet
Other Name: Donepezil (generic name)

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Method: FDA Bioequivalence Statistical Methods

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  • All 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 1 year prior to the 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 at 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 urine drug screen at screening.
  • History of allergic reactions to donepezil, piperidine derivatives, or other related drugs.
  • Use of any drugs known to induce of inhibit hepatic drug metabolism (example of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants, cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to the administration of the study medications.
  • 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 administration of study medication or over-the-counter products (including natural food supplements, vitamins, or garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption and hormonal contraceptives.
  • Difficulty to swallow study medication.
  • Use of 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 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 or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439243

Locations
Canada, Quebec
Anapharm
Montreal, Quebec, Canada, H3X 2H9
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Benoit J Deschamps, M.D. Anapharm
  More Information

No publications provided

Responsible Party: Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01439243     History of Changes
Other Study ID Numbers: 70186
Study First Received: September 20, 2011
Last Updated: September 20, 2011
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects
Donepezil

Additional relevant MeSH terms:
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014