Donepezil 10 mg Tablets Under Fed Conditions

NCT01439243 | Completed Phase 1

• 1 other identifier: 70186
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects; Donepezil

Outcome Measures

Primary Outcomes (2)

• Cmax of Donepezil.

  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.

  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.

Study Arms (2)

Investigational Test Product

EXPERIMENTAL

Donepezil 10 mg Tablets

Drug: Donepezil

Reference Listed Drug

ACTIVE COMPARATOR

Aricept® 10 mg Tablets

Drug: Aricept®

Interventions

Donepezil DRUG

10 mg Tablet

Investigational Test Product

Aricept® DRUG

10 mg Tablet

Also known as: Donepezil (generic name)

Reference Listed Drug

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Anapharm

Montreal, Quebec, H3X 2H9, Canada

Location

MeSH Terms

Interventions

Donepezil

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Benoit J Deschamps, M.D.

  Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 23, 2011
• Study Start: June 1, 2007
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: September 23, 2011

Record last verified: 2011-09

Locations

CA (1)