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

NCT03902574 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-07-20

Study results available
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Summary

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

Conditions

  • Healthy Adult Male

Interventions

DRUG

Brexpiprazole ODT 2mg with water

Brexpiprazole ODT 2mg is administered with water.

DRUG

Brexpiprazole ODT 2mg without water

Brexpiprazole ODT 2mg is administered without water.

DRUG

Brexpiprazole conventional tablet 2mg

Brexpiprazole conventional tablet 2mg is administered with water.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Osamu Sato · Otsuka Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
39 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-27
Primary Completion
2019-06-18
Completion
2019-06-18

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03902574 on ClinicalTrials.gov