A Bioequivalence Study of Film-coated Tablet and Dry Syrup 1% Form for E2020 in Healthy Japanese Adult Males

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01506739
First received: January 6, 2012
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

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 Japanese healthy adult males.


Condition Intervention Phase
Healthy Adult
Drug: Donepezil Hydrochloride
Drug: Donepezil Hydrochloride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Bioequivalence Study of Film-coated Tablet and Dry Syrup 1% Form for E2020 in Healthy Japanese Adult Males

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • PK Parameter Cmax, calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated. [ Time Frame: Up to 168 hrs after administration ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: March 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Donepezil Hydrochloride
Drug E2020 film-coated tablet: E2020 film-coated tablet (5mg) orally administered in a single dose with 200 mL water.
Active Comparator: 2 Drug: Donepezil Hydrochloride
Drug E2020 dry syrup 1% form (suspended): E2020 dry syrup 1% (0.5 g) will be orally administered in a single dose after suspended in 20 ml water.
Active Comparator: 3 Drug: Donepezil Hydrochloride
Drug E2020 dry syrup 1% form: E2020 dry syrup 1% (0.5 g) will be orally administered in a single dose with 200 mL water.

  Eligibility

Ages Eligible for Study:   20 Years to 44 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

Those who meet all below criteria are eligible to enroll in this study;

  1. Those who provide consent by their own will.
  2. 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)
  3. BMI at screening is 18.5 kg/m2 or above and less than 25.0 kg/m2
  4. 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.

  1. 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.
  2. 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.
  3. 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.
  4. Subjects who have any history of medically significant allergy to medications or foods, and those who currently have any symptoms of seasonal
  5. Subjects whose weight changes were more than 10% from the screening phase to study drug administration.
  6. 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.
  7. Corrected change in QT wave (QTc) interval of > 450 msec with 12-lead EKG at screening or study drug administration.
  8. Subjects who are positive for hepatitis B surface antigen (HBs antigen), hepatitis C (HCV) antibody, or serologic test for syphilis (STS).
  9. 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.
  10. Subjects who consumed caffeine-containing food or beverages within 72 hours before study drug administration.
  11. 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.
  12. Exposure to St. John's wort containing medications within 4 weeks of study drug administration.
  13. Use of any prescription drugs within 4 week before study drug administration.
  14. Use of any OTC medications within 2 week before study drug administration.
  15. Subjects who enrolled in another clinical trial and exposed to any investigational drug within 16 weeks of study enrollment.
  16. 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.
  17. Subjects who performed extreme exercises or exhausting labors (more than 1 hr/day or 5 day/week) within 2 weeks before hospitalization.
  18. Any subject who, or whose partner, does not want to take highly reliable contraceptive measures until the end of the post-treatment examination.
  19. Subjects who are inappropriate to participate in the study, as judged by the investigator or subinvestigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506739

Locations
Japan
Sumida-ku, Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Hiroki Shimizu Eisai Co., Ltd.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01506739     History of Changes
Other Study ID Numbers: E2020-J081-033
Study First Received: January 6, 2012
Last Updated: January 9, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Bioequivalence
Healthy Subjects
Donepezil

Additional relevant MeSH terms:
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014