Bioequivalence Study of Brexpiprazole Orally Disintegrating Tablets (ODT) 2mg

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-27

Study Completion Date

2019-06-18

Brief Summary

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To investigate the bioequivalence of brexpiprazole ODT 2 mg and brexpiprazole conventional tablet 2 mg

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Detailed Description

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Conditions

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Healthy Adult Male

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Brexpiprazole ODT 2mg with water

Brexpiprazole ODT 2mg is administered with water.

Group Type EXPERIMENTAL

Brexpiprazole ODT 2mg with water

Intervention Type DRUG

Brexpiprazole ODT 2mg is administered with water.

Brexpiprazole ODT 2mg without water

Brexpiprazole ODT 2mg is administered without water.

Group Type EXPERIMENTAL

Brexpiprazole ODT 2mg without water

Intervention Type DRUG

Brexpiprazole ODT 2mg is administered without water.

Brexpiprazole conventional tablet 2mg

Brexpiprazole conventional tablet 2mg is administered with water.

Group Type EXPERIMENTAL

Brexpiprazole conventional tablet 2mg

Intervention Type DRUG

Brexpiprazole conventional tablet 2mg is administered with water.

Interventions

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Brexpiprazole ODT 2mg with water

Brexpiprazole ODT 2mg is administered with water.

Intervention Type DRUG

Brexpiprazole ODT 2mg without water

Brexpiprazole ODT 2mg is administered without water.

Intervention Type DRUG

Brexpiprazole conventional tablet 2mg

Brexpiprazole conventional tablet 2mg is administered with water.

Intervention Type DRUG

Other Intervention Names

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OPC-34712 OD OPC-34712 OD OPC-34712 conventional tablet

Eligibility Criteria

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Inclusion Criteria

* Healthy Japanese males
* BMI ［body weight in kg /(height in m)2］ of at least 18.5 kg/m2 and less than 25.0 kg/m2 (as a result of at the screening examination)
* Capable of providing written informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the investigator, to comply with all requirements of the trial

Exclusion Criteria

* Clinically significant abnormality at the time of screening (eg, significant deviation from reference ranges) or in medical history that, in the opinion of investigator, subinvestigator, or sponsor may place the subject at risk or interfere with outcome variables such as drug absorption, distribution, metabolism, and excretion
* History of serious mental disorder
* History of drug or alcohol abuse within 2 years prior to screening
* History of any significant drug allergy
* Use of another investigational drug within 120 days prior to the first administration of IMP
* Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange products, Star fruit, or Star fruit products within 72 hours prior to the first administration of IMP or consumption of alcohol within 72 hours prior to administration of IMP
* Use of prescription, over-the-counter (OTC), or herbal medication, or vitamin supplements, or consumption of food or beverages containing St. John's Wort within 14 days prior to the first administration of IMP, or use of antibiotics within 30 days prior to the first administration of IMP
* History of major surgery of the digestive tract (excluding appendectomy)
* Any subject who, in the judgement of the investigator or subinvestigator, should not participate in the trial

Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes