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Completed Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT07253441

Public ClinicalTrials.gov record NCT07253441. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 3:40 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07253441
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
174 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 29, 2024 (Actual)
Primary completion
Dec 30, 2024 (Actual)
Completion
Dec 30, 2024 (Actual)
Last update posted
Dec 11, 2025

2024

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
ICON Lenexa Lenexa Kansas 66219 —
ICON Salt Lake City Millcreek Utah 84124 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07253441, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 11, 2025 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07253441 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →