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

Healthy Adult Male Clinical Trial

Official title:
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

Status Completed

Clinical Trial 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)).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Healthy Adult Male

Clinical Trial Details

NCT number	NCT02875080
Study type	Interventional
Source	Otsuka Pharmaceutical Co., Ltd.
Contact
Status	Completed
Phase	Phase 1
Start date	September 27, 2016
Completion date	November 27, 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04182958` - A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects	Phase 1
Completed	`NCT03902574` - Bioequivalence Study of Brexpiprazole Orally Disintegrating Tablets (ODT) 2mg	Phase 1
Completed	`NCT05439148` - OPC-61815 in Healthy Chinese Male Subjects	Phase 1
Completed	`NCT02994394` - A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects	Phase 1
Completed	`NCT04415645` - Absorption, Metabolism, Excretion, and Mass Balance Study of [14C]-VVZ-149 in Healthy Adult Male Subjects	Phase 1
Completed	`NCT01423435` - Study to Compare Pharmacokinetic Profiles of TRK-100STP in Japanese, Chinese, and South Korean Non-elderly Healthy Adult Males	Phase 1
Completed	`NCT01258699` - A Study Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects	Phase 1