drugset / Trial / 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

NCT07253441

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2024-08-29
Primary completion
2024-12-30
Completion
2024-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Centanafadine Small molecule 164.4 mg Oral
Subject Centanafadine Small molecule 200 mg Oral
Subject Centanafadine Small molecule 328.8 mg Oral
Subject Centanafadine Small molecule 400 mg Oral