HealthyPhase 1NCT01439243
Donepezil 10 mg Tablets Under Fed Conditions
A Phase 1 study testing Donepezil and Aricept® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Donepezil and Aricept®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2007to Jul 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Method: FDA Bioequivalence Statistical Methods
- Conditions
- Healthy
- Being tested
- Donepezil, Aricept®
- Keywords
- Bioequivalence, Healthy Subjects, Donepezil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
10 mg Tablet
Aricept®Drug
Also called Donepezil (generic name)
10 mg Tablet
| Study group | Role | What they receive |
|---|---|---|
| Investigational Test Product | Experimental | Donepezil 10 mg Tablets Receives: Drug: Donepezil |
| Reference Listed Drug | Active comparator | Aricept® 10 mg Tablets Receives: Drug: Aricept® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Donepezil.
Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).
Measured: 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).
Measured: Blood samples collected over a 72 hour period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startJun 2007
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benoit J Deschamps, M.D., Principal investigator, Anapharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439243
- Sponsor's protocol ID
- 70186
- Status last verified
- Sep 2011
- First submitted
- 20 Sep 2011
- Last updated
- 23 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01439243
- Acronym / sponsor ID
- 70186
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects, Donepezil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 23 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Method: FDA Bioequivalence Statistical Methods
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Test Product | Experimental | Drug: DonepezilDonepezil 10 mg Tablets |
| Reference Listed Drug | Active comparator | Drug: Aricept®Aricept® 10 mg Tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezil10 mg Tablet | Drug | Investigational Test Product |
| Aricept®Also: Donepezil (generic name)10 mg Tablet | Drug | Reference Listed Drug |
Primary outcome
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit J Deschamps, M.D. principal investigator
Anapharm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Donepezil and Aricept® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of Donepezil. (time frame: Blood samples collected over a 72 hour period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2011.