- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01506752
A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males
June 25, 2012 updated by: Eisai Co., Ltd.
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 Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tokyo
-
Sumida-ku, Tokyo, Japan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 44 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria
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.
Exclusion Criteria
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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: E2020 improved 10 mg without water
|
improved orally disintegrating E2020 10 mg tablet without water.
current orally disintegrating E2020 10 mg tablet without water.
improved orally disintegrating E2020 10 mg tablet with water.
current orally disintegrating E2020 10 mg tablet with water
|
Active Comparator: E2020 current 10 mg without water
|
improved orally disintegrating E2020 10 mg tablet without water.
current orally disintegrating E2020 10 mg tablet without water.
improved orally disintegrating E2020 10 mg tablet with water.
current orally disintegrating E2020 10 mg tablet with water
|
Active Comparator: E2020 improved 10 mg with water
|
improved orally disintegrating E2020 10 mg tablet without water.
current orally disintegrating E2020 10 mg tablet without water.
improved orally disintegrating E2020 10 mg tablet with water.
current orally disintegrating E2020 10 mg tablet with water
|
Active Comparator: E2020 current 10 mg with water
|
improved orally disintegrating E2020 10 mg tablet without water.
current orally disintegrating E2020 10 mg tablet without water.
improved orally disintegrating E2020 10 mg tablet with water.
current orally disintegrating E2020 10 mg tablet with water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PK Parameter Cmax, calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated.
Time Frame: Up to 168 hrs after administration
|
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
|
Up to 168 hrs after administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hiroki Shimizu, Eisai Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
January 6, 2012
First Submitted That Met QC Criteria
January 9, 2012
First Posted (Estimate)
January 10, 2012
Study Record Updates
Last Update Posted (Estimate)
June 27, 2012
Last Update Submitted That Met QC Criteria
June 25, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2020-J081-034
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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