Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-22

Study Completion Date

2019-05-09

Brief Summary

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To evaluate the single-dose bioequivalence of oral suspension and intravenous (IV) formulation of edaravone in the fasting state in healthy adult subjects

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Detailed Description

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Conditions

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Healthy Adult Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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MT-1186

Healthy subjects were administered a single dose of Edaravone oral suspension

Group Type EXPERIMENTAL

MT-1186

Intervention Type DRUG

Oral suspension

MCI-186

Healthy subjects were administered a single dose of Edaravone intravenous formulation

Group Type ACTIVE_COMPARATOR

MCI-186

Intervention Type DRUG

Intravenous formulation

Interventions

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MT-1186

Oral suspension

Intervention Type DRUG

MCI-186

Intravenous formulation

Intervention Type DRUG

Other Intervention Names

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Edaravone Edaravone

Eligibility Criteria

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Inclusion Criteria

* Healthy adult male or female volunteers
* Japanese
* Subjects aged between 20 and 45 years at the time of informed consent
* Subjects who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study

Exclusion Criteria

* Subjects with a current or previous history of cardiac, hepatic, renal, gastrointestinal, respiratory, psychiatric/nervous, hematopoietic, or endocrine diseases, and those whom the investigator (or subinvestigator) deems unsuitable for the study
* Body mass index (BMI) of \<18.0 or \>30.0, or body weight of \<50 kg (BMI formula: body weight \[kg\]/height \[m\]2, rounded to one decimal place)
* Subjects who have undergone any surgery known to affect the gastrointestinal absorption of drugs
* Female subjects who do not agree to use an effective method of contraception from screening or 2 weeks before the start of investigational product administration, whichever comes earlier, to 14 days after the completion (or discontinuation) of investigational product administration. Male subjects who do not agree to use an effective method of contraception from the start of investigational product administration to 14 days after the completion (or discontinuation) of investigational product administration
* Subjects who have previously received edaravone
* Subjects who have participated in another clinical study and received an investigational product within 12 weeks before providing informed consent

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes