NCT07253441

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

A Multiple-arm, Phase 1, Open-label Trial to Determine Dose Strength Equivalence and Effect of Food on To-Be-Marketed Centanafadine QD XR Capsules, Bioequivalence Between Clinical and To-Be-Marketed QD XR Capsules and Relative Bioavailability of To-Be-Marketed QD XR Capsules to SR Tablets in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DRUG	CTN XR (TBM)	Oral capsules
DRUG	CTN SR	Oral tablets
DRUG	CTN XR (Clin)	Oral capsules

Timeline

• Start date: 2024-08-29
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2025-11-28
• Last updated: 2025-12-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study