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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Male

Treatments: Drug: Brexpiprazole ODT 2mg without water; Drug: Brexpiprazole ODT 2mg with water; Drug: Brexpiprazole conventional tablet 2mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03902574

JapicCTI-194655 (Other Identifier)

331-14-002

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: Male

Ages: 20 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Brexpiprazole ODT 2mg with water

Experimental group

Description:

Brexpiprazole ODT 2mg is administered with water.

Treatment:

Drug: Brexpiprazole ODT 2mg with water

Brexpiprazole ODT 2mg without water

Experimental group

Description:

Brexpiprazole ODT 2mg is administered without water.

Treatment:

Drug: Brexpiprazole ODT 2mg without water

Brexpiprazole conventional tablet 2mg

Experimental group

Description:

Brexpiprazole conventional tablet 2mg is administered with water.

Treatment:

Drug: Brexpiprazole conventional tablet 2mg