Status:
COMPLETED
A Bioequivalence Study of Film-coated Tablet and Dry Syrup 1% Form for E2020 in Healthy Japanese Adult Males
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Healthy Adult
Eligibility:
MALE
20-44 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to confirm bioequivalence between E2020 dry syrup 1% form (0.5 g), given either with 200 mL of water or suspended in 20 mL of water, and E2020 film-coated tablet (5 mg) in...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01506739
Start Date
March 1 2011
End Date
May 1 2011
Last Update
January 10 2012
Active Locations (1)
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1
Sumida-ku, Tokyo, Japan