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Evaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Evaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects

A Single-center, Open-label, Randomized, Three-way, Crossover Trial to Evaluate the Bioavailability of Brexpiprazole (OPC-34712) Orally Disintegrating Tablets Relative to Brexpiprazole (OPC-34712) Conventional Tablets in Healthy Male Subjects

NCT02875080•Otsuka Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The ratios of the geometric means of the ODT formulation to those of the reference formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of brexpiprazole (OPC-34712)).

Eligibility

Age

20 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•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 or sponsor may place the subject at risk or interfere with outcome variables, including 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 an investigational drug within 120 days prior to the first dosing of trial drug
•Use of tobacco products or daily exposure to secondhand smoke within 2 months prior to screening
•Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange products, starfruit, or starfruit products within 72 hours prior to dosing
•Use of prescription, over-the-counter, or herbal medication, vitamin supplements, or St. John's Wort within 14 days prior to the first dosing of trial drug, or of antibiotics within 30 days prior to the first dosing of trial drug
•History of major surgery of the digestive tract (excluding appendectomy)
•Any subject who, in the opinion of the investigator, should not participate in the trial

Locations (1)

Kyusyu Region, Japan

Key Dates

Start Date

September 27, 2016

Primary Completion Date

November 27, 2016

Completion Date

November 27, 2016

Last Updated

February 23, 2021

Enrollment

ACTUAL participants

Conditions

Healthy Adult Male

Interventions

OPC-34712

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects

Inclusion Criteria

Exclusion Criteria

Evaluation of MTX-463 Administered Subcutaneously in Healthy Adult Males

Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt and Evaluation of Potential Drug-Drug Interactions

Safety and Pharmacokinetics of Y-4 Tablets in Healthy Subjects

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