A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males

NCT01506752 | Completed Phase 1

• 1 other identifier: E2020-J081-034
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy Adult

Keywords

Bioequivalence; Healthy Subjects; Donepezil

Outcome Measures

Primary Outcomes (2)

• PK Parameter Cmax, calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated.

  Up to 168 hrs after administration

• PK Parameter AUC(0-168), calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated.

  Up to 168 hrs after administration

Study Arms (4)

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

Interventions

Donepezil Hydrochloride DRUG

improved orally disintegrating E2020 10 mg tablet without water.

E2020 improved 10 mg without water

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Sumida-ku, Tokyo, Japan

Location

MeSH Terms

Interventions

Donepezil

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Hiroki Shimizu

  Eisai Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 10, 2012
• Study Start: July 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 27, 2012

Record last verified: 2012-01

Locations

JP (1)