HealthyPhase 1NCT01260948

10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions

A Phase 1 study testing Donepezil Hydrochloride and Aricept® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study investigated the relative bioavailability (rate and extend of absorption) of Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai Inc., following a single oral dose (1 x 10 mg orally… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Donepezil Hydrochloride 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 siteUnited States
Study dates: Apr 2006to May 2006
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Screening Demographics: All volunteers selected for this study will be healthy men and women 18 years of age or older at the time of dosing. The weight range will not exceed + 20% for height and weight as per Desirable Weights for Adults - 1983 Metropolitan Height and Weight Table.
Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
If female and:
of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s); or
is postmenopausal for at least 1 year; or
is surgically sterile.

Who cannot join

Volunteers with a recent history of drug or alcohol addiction or abuse.
Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic systems(s) or psychiatric disease (as determined by the clinical investigators).
Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on reexamination are deemed to be clinically significant.
Volunteers demonstrating a reactive screen for Hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
Volunteers demonstrating a positive drug abuse screen when screened for this study.
Female volunteers demonstrating a positive pregnancy screen.

Show all 17Show fewer

Female volunteers who are currently breastfeeding.
Volunteers with a history of allergic response(s) to donepezil or related drugs.
Volunteers with a history of clinically significant allergies including drug allergies.
Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
Volunteers who currently use tobacco products.
Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
Volunteers who report donating greater than 150 mL of blood within 28 days prior to Period I dosing.
Volunteers who have donated plasma within 14 days of Period I dosing.
Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing.
Volunteers who report taking any systemic prescription medication in the 14 days prior to Period I dosing.
Female volunteers who report the use of oral contraceptives or injectable contraceptives.

Trial locations and contacts

1 site in 1 country.

United States1 site

PRACS Institute, Ltd.
East Grand Forks, Minnesota, 56721

Other trials in United States

About this study

Official title: A Relative Bioavailability Study of 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions.

Conditions: Healthy
Being tested: Donepezil Hydrochloride, Aricept®
Keywords: Bioequivalence, Healthy Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Donepezil HydrochlorideDrug
10 mg Orally Disintegrating Tablet
Aricept®Drug
Also called Donepezil Hydrochloride (generic name)
10 mg Orally Disintegrating Tablet

Study groups in NCT01260948
Study group	Role	What they receive
Investigational Test Product	Experimental	Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg Receives: Drug: Donepezil Hydrochloride
Reference Listed Drug	Active comparator	Aricept® Orally Disintegrating Tablets, 10 mg 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-t of Donepezil.
Bioequivalence based on Donepezil AUC0-t (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.

Apr 2006May 2006

First posted15 Dec 2010 (estimated)
Study startApr 2006
Primary completionMay 2006
Study completionMay 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01260948
Sponsor's protocol ID: R05-1255
Status last verified: Jan 2011
First submitted: 14 Dec 2010
Last updated: 21 Feb 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Relative Bioavailability Study of 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions.
ClinicalTrials.gov ID: NCT01260948
Acronym / sponsor ID: R05-1255
Conditions: Healthy
Keywords: Bioequivalence, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: May 2006 (actual)
Study completion: May 2006 (actual)
First posted: 15 Dec 2010 (estimated)
Results: Posted 21 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Investigational Test Product	Experimental	Drug: Donepezil HydrochlorideDonepezil Hydrochloride Orally Disintegrating Tablets, 10 mg
Reference Listed Drug	Active comparator	Drug: Aricept®Aricept® Orally Disintegrating Tablets, 10 mg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Screening Demographics: All volunteers selected for this study will be healthy men and women 18 years of age or older at the time of dosing. The weight range will not exceed + 20% for height and weight as per Desirable Weights for Adults - 1983 Metropolitan Height and Weight Table.
Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
If female and:

Key exclusion criteria (17 listed)

Volunteers with a recent history of drug or alcohol addiction or abuse.
Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic systems(s) or psychiatric disease (as determined by the clinical investigators).
Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on reexamination are deemed to be clinically significant.
Volunteers demonstrating a reactive screen for Hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
Volunteers demonstrating a positive drug abuse screen when screened for this study.

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
Donepezil Hydrochloride10 mg Orally Disintegrating Tablet	Drug	Investigational Test Product
Aricept®Also: Donepezil Hydrochloride (generic name)10 mg Orally Disintegrating 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-t of Donepezil.
Time frame: Blood samples collected over a 72 hour period.
Bioequivalence based on Donepezil AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).

Results and safety

Results posted to the registry on 21 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Donepezil Hydrochloride (Test) First	13	13
Aricept® (Reference) First	13	13

Primary outcome: Cmax of Donepezil.

Time frame: Blood samples collected over a 72 hour period.. Mean (Standard Deviation). Unit: ng/mL

Measure	Donepezil Hydrochloride (Test) n = 21	Aricept® (Reference) n = 21
Value	15627.68 (2639.13)	15687.09 (2212.97)

Donepezil Hydrochloride (Test) vs Aricept® (Reference): Ratio of the T/R geometric mean x 100: 98.72 (90% CI 94.13 to 103.53)

Population analysed: All participants that completed the study had their samples analyzed.

Primary outcome: AUC0-t of Donepezil.

Time frame: Blood samples collected over a 72 hour period.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Donepezil Hydrochloride (Test) n = 21	Aricept® (Reference) n = 21
Value	459278.68 (106883.97)	479159.80 (98511.14)

Donepezil Hydrochloride (Test) vs Aricept® (Reference): Ratio of the T/R geometric mean x 100: 94.81 (90% CI 91.30 to 98.47)

Population analysed: All participants that completed the study had their samples analyzed.

Adverse events

Time frame: Adverse event data was collected over the course of the study, which was approximately 8 weeks in duration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Donepezil Hydrochloride (Test) First	0 of 26 (0%)	5 of 26 (19.2%)	Not reported
Aricept® (Reference) First	0 of 26 (0%)	5 of 26 (19.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

James D Carlson, Pharm.D. principal investigator

PRACS Institute, Ltd.

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 Hydrochloride and Aricept® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.

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 6 inclusion and 17 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 21 Feb 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 United States. 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?

Yes. Results are posted in the registry (first posted 21 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

On the ClinicalTrials.gov record for NCT01260948.

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 21 Feb 2011.