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

Healthy Adult Male Clinical Trial

Official title:

A Single Center, Open-label, Randomized, 3-arm, 3-way, Crossover Trial to Investigate the Bioequivalence of Brexpiprazole (OPC-34712) Orally Disintegrating Tablets in Healthy Adult Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902574
• Other study ID #: 331-14-002
• Secondary ID: JapicCTI-194655
• Status: Completed
• Phase: Phase 1
• Start date: March 27, 2019
• Est. completion date: June 18, 2019

Study information

• Verified date: June 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 18, 2019
• Est. primary completion date: June 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adult Male

Intervention

Drug:
• Brexpiprazole ODT 2mg with water
Brexpiprazole ODT 2mg is administered with water.
• Brexpiprazole ODT 2mg without water
Brexpiprazole ODT 2mg is administered without water.
• Brexpiprazole conventional tablet 2mg
Brexpiprazole conventional tablet 2mg is administered with water.

Locations

Country	Name	City	State
Japan	SOUSEIKAI Hakata clinic	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum (Peak) Plasma Concentration (Cmax) of Brexpiprazole		Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12,16, 24, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours postdose
Primary	Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Brexpiprazole		Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12,16, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 312 hours postdose