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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Subjects

Treatments: Drug: MT-1186; Drug: MCI-186

Study type: Interventional

Funder types: Industry

Identifiers

NCT04493281

MT-1186-J03

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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: Additional screening criteria check may apply for qualification:

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

MT-1186

Experimental group

Description:

Healthy subjects were administered a single dose of Edaravone oral suspension

Treatment:

Drug: MT-1186

MCI-186

Active Comparator group

Description:

Healthy subjects were administered a single dose of Edaravone intravenous formulation

Treatment:

Drug: MCI-186