Healthy AdultPhase 1NCT01506752
A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males
A Phase 1 study testing Donepezil Hydrochloride in people with Healthy Adult, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to investigate the bioequivalence of improved and current orally disintegrating E2020 10 mg tablets as a single dose in Japanese healthy adult males for each of two administration methods (with/without water). Read more about this study
- Who is it for?
- Ages 20 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- Donepezil Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2011to Sep 2011
- 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 20 to 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those who meet all below criteria are eligible to enroll in this study;
- Those who provide consent by their own will.
- Male subjects aged between ≥ 20 years and < 45 years old at the time of obtaining informed consent and non-smoker (subjects who have not been smoking for at least 4 weeks prior to study treatment)
- BMI at screening is 18.5 kg/m2 or above and less than 25.0 kg/m2
- Those who are willing to and can comply with the conditions described in the study protocol.
Who cannot join
- Those who meet any of the below criteria will be excluded from the study.
- Any significant medical illness that required intervention within 8 weeks before treatment, or any medical history of clinically significant infectious diseases within 4 weeks before treatment.
- Those who had any psychiatric, GI tract, hepatic, renal, respiratory, endocrine, hematological, neurological, cardiovascular diseases or congenital metabolic disorders within 4 weeks before study drug administration that may have an impact on the evaluation of the drug.
- Subjects who have any medical history of GI, hepatic, or renal surgery (e.g. excision of liver, kidney or GI tract) that may have an impact on pharmacokinetics of the drug.
- Subjects who have any history of medically significant allergy to medications or foods, and those who currently have any symptoms of seasonal
- Subjects whose weight changes were more than 10% from the screening phase to study drug administration.
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- Those with clinical abnormal symptoms, medical history of organ dysfunction, subjective symptoms, objective findings, vital signs, and abnormal EKG or clinical laboratory test values, which need medical intervention.
- Corrected change in QT wave (QTc) interval of > 450 msec with 12-lead EKG at screening or study drug administration.
- Subjects who are positive for hepatitis B surface antigen (HBs antigen), hepatitis C (HCV) antibody, or serologic test for syphilis (STS).
- Subjects who are suspected with or who has a history of drug or alcohol abuse, or positive urine screen for drugs of abuse or exhalation alcohol test at screening or baseline.
- Subjects who consumed caffeine-containing food or beverages within 72 hours before study drug administration.
- Exposure to any supplements or herbs (including Chinese medicine), or beverages (e.g. alcohol or grapefruit-containing beverages, within 2 weeks of study drug administration.
- Exposure to St. John's wort containing medications within 4 weeks of study drug administration.
- Use of any prescription drugs within 4 week before study drug administration.
- Use of any OTC medications within 2 week before study drug administration.
- Subjects who enrolled in another clinical trial and exposed to any investigational drug within 16 weeks of study enrollment.
- Subjects who received blood infusion within 12 weeks, those who had blood drawn 400 mL or more within 12 weeks, 400 mL, or 200 mL or more within 4 weeks, or sampling of a component of the blood within 2 week of study drug administration.
- Subjects who performed extreme exercises or exhausting labors (more than 1 hr/day or 5 day/week) within 2 weeks before hospitalization.
- Any subject who, or whose partner, does not want to take highly reliable contraceptive measures until the end of the post-treatment examination.
- Subjects who are inappropriate to participate in the study, as judged by the investigator or subinvestigator
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the bioequivalence of improved and current orally disintegrating E2020 10 mg tablets as a single dose in Japanese healthy adult males for each of two administration methods (with/without water).
- Conditions
- Healthy Adult
- Being tested
- Donepezil Hydrochloride
- Keywords
- Bioequivalence, Healthy Subjects, Donepezil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil HydrochlorideDrug
improved orally disintegrating E2020 10 mg tablet without water.
Donepezil HydrochlorideDrug
current orally disintegrating E2020 10 mg tablet without water.
Donepezil HydrochlorideDrug
improved orally disintegrating E2020 10 mg tablet with water.
Donepezil HydrochlorideDrug
current orally disintegrating E2020 10 mg tablet with water
| Study group | Role | What they receive |
|---|---|---|
| E2020 improved 10 mg without water | Active comparator | Not described Receives: Drug: Donepezil Hydrochloride |
| E2020 current 10 mg without water | Active comparator | Not described Receives: Drug: Donepezil Hydrochloride |
| E2020 improved 10 mg with water | Active comparator | Not described Receives: Drug: Donepezil Hydrochloride |
| E2020 current 10 mg with water | Active comparator | Not described Receives: Drug: Donepezil Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK Parameter Cmax, calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated.
Measured: Up to 168 hrs after administration
PK Parameter AUC(0-168), calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated.
Measured: Up to 168 hrs after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startJul 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hiroki Shimizu, Study director, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506752
- Sponsor's protocol ID
- E2020-J081-034
- Status last verified
- Jan 2012
- First submitted
- 6 Jan 2012
- Last updated
- 27 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males
- ClinicalTrials.gov ID
- NCT01506752
- Acronym / sponsor ID
- E2020-J081-034
- Conditions
- Healthy Adult
- Keywords
- Bioequivalence, Healthy Subjects, Donepezil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 10 Jan 2012 (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 purpose of this study is to investigate the bioequivalence of improved and current orally disintegrating E2020 10 mg tablets as a single dose in Japanese healthy adult males for each of two administration methods (with/without water).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| E2020 improved 10 mg without water | Active comparator | Drug: Donepezil Hydrochloride |
| E2020 current 10 mg without water | Active comparator | Drug: Donepezil Hydrochloride |
| E2020 improved 10 mg with water | Active comparator | Drug: Donepezil Hydrochloride |
| E2020 current 10 mg with water | Active comparator | Drug: Donepezil Hydrochloride |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Those who meet all below criteria are eligible to enroll in this study;
- Those who provide consent by their own will.
- Male subjects aged between ≥ 20 years and < 45 years old at the time of obtaining informed consent and non-smoker (subjects who have not been smoking for at least 4 weeks prior to study treatment)
- BMI at screening is 18.5 kg/m2 or above and less than 25.0 kg/m2
- Those who are willing to and can comply with the conditions described in the study protocol.
Key exclusion criteria (20 listed)
- Those who meet any of the below criteria will be excluded from the study.
- Any significant medical illness that required intervention within 8 weeks before treatment, or any medical history of clinically significant infectious diseases within 4 weeks before treatment.
- Those who had any psychiatric, GI tract, hepatic, renal, respiratory, endocrine, hematological, neurological, cardiovascular diseases or congenital metabolic disorders within 4 weeks before study drug administration that may have an impact on the evaluation of the drug.
- Subjects who have any medical history of GI, hepatic, or renal surgery (e.g. excision of liver, kidney or GI tract) that may have an impact on pharmacokinetics of the drug.
- Subjects who have any history of medically significant allergy to medications or foods, and those who currently have any symptoms of seasonal
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 Hydrochlorideimproved orally disintegrating E2020 10 mg tablet without water. | Drug | E2020 improved 10 mg without water |
| Donepezil Hydrochloridecurrent orally disintegrating E2020 10 mg tablet without water. | Drug | E2020 current 10 mg without water |
| Donepezil Hydrochlorideimproved orally disintegrating E2020 10 mg tablet with water. | Drug | E2020 improved 10 mg with water |
| Donepezil Hydrochloridecurrent orally disintegrating E2020 10 mg tablet with water | Drug | E2020 current 10 mg with water |
Primary outcome
PK Parameter Cmax, calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated.
Time frame: Up to 168 hrs after administration
PK Parameter AUC(0-168), calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated.
Time frame: Up to 168 hrs after administration
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 27 Jun 2012.
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Healthy Participants
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.
Hiroki Shimizu study director
Eisai Co., 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 in people with Healthy Adult, run by Eisai Co., Ltd. at 1 site in Japan.
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 5 inclusion and 20 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 27 Jun 2012. 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 Japan. 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?
PK Parameter Cmax, calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated. (time frame: Up to 168 hrs after administration). 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 27 Jun 2012.