Overview

A Trial to Characterize Differences in Blood Levels of Different Lots of Centanafadine QD XR and to Understand the Effect of Food on Blood Levels

Status:
COMPLETED

Trial end date:
2024-12-30

Target enrollment:

Participant gender:

Summary

The purpose of this study is to evaluate the dose strength equivalence of to-be-marketed (TBM) centanafadine (CTN) once daily (QD) extended release (XR) when administered as 2 capsules of 164.4 milligrams (mg) or as a single capsule of 328.8 mg, effect of food on the absorption of the TBM CTN QD XR capsule, and relative bioavailability of clinical (Clin) CTN sustained release (SR) tablets to the TBM CTN QD XR capsules.

Phase:

PHASE1

Details

Lead Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Treatments:

1-(naphthalen-2-yl)-3-azabicyclo(3.1.0)hexane