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

Phase 1

Completed

• Conditions: Healthy Adult Male
• Interventions: Drug: Brexpiprazole ODT 2mg without water; Drug: Brexpiprazole conventional tablet 2mg; Drug: Brexpiprazole ODT 2mg with water

• Registration Number: NCT03902574
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-27
• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-04
• Primary Completion: 2019-06-18
• Study Completion: 2019-06-18
• Status Verified: 2021-06
• Results First Submitted: 2021-06-30
• Results First Submitted QC: 2021-06-30
• Last Update Submitted: 2021-06-30
• Results First Posted: 2021-07-20
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brexpiprazole ODT 2mg without water	Brexpiprazole ODT 2mg without water	Brexpiprazole ODT 2mg is administered without water.
Brexpiprazole conventional tablet 2mg	Brexpiprazole conventional tablet 2mg	Brexpiprazole conventional tablet 2mg is administered with water.
Brexpiprazole ODT 2mg with water	Brexpiprazole ODT 2mg with water	Brexpiprazole ODT 2mg is administered with water.

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

SOUSEIKAI Hakata clinic; 🇯🇵 Fukuoka, Japan