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NCT07486895 · ClinicalTrials.gov registry record · Phase 1

Trial to Demonstrate the Equivalence of Two Different Strengths of Oral Centanafadine Capsules in Healthy Subjects

A Phase 1 study of Healthy Adult Participants, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 1
Development phase
44
Enrollment target
1
Study location

NCT07486895: Completed Phase 1 study of Healthy Adult Participants, sponsored by Otsuka Pharmaceutical Development & Commercialization.

NCT07486895 is a Phase 1 study of Healthy Adult Participants that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 44 participants, below the 69-participant average among 4 other Healthy Adult Participants trials with a reported enrollment target (36% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07486895, a Phase 1 study of Healthy Adult Participants, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 1
Development phase
44 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to demonstrate dose strength equivalence of 2 × 164.4 milligrams (mg) centanafadine (CTN) once daily (QD) extended-release (XR) capsules to a 1 × 328.8 mg centanafadine QD XR capsule in healthy adult participants.

Conditions Studied

Interventions

  • DRUG Centanafadine

Study Locations (1)

Kansas

  • ICON plc - Lenexa

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2023-03-08
Est. Completion 2023-05-18
Phase Phase 1

What the finished NCT07486895 record still lists

NCT07486895 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 69-participant average among 4 other Healthy Adult Participants trials with a reported enrollment target (36% lower).

The record links to 1 condition, with Healthy Adult Participants appearing as the primary indexed condition, and to 1 intervention - of which Centanafadine is the first listed.

NCT07486895 reports a single indexed study location in Kansas.

Frequently Asked Questions

What is clinical trial NCT07486895 about?

NCT07486895 is a clinical study titled "Trial to Demonstrate the Equivalence of Two Different Strengths of Oral Centanafadine Capsules in Healthy Subjects". The purpose of this study is to demonstrate dose strength equivalence of 2 × 164.4 milligrams (mg) centanafadine (CTN) once daily (QD) extended-release (XR) capsules to a 1 × 328.8 mg centanafadine QD XR capsule in healthy adult participants.

What is the current status of trial NCT07486895?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2023-03-08. Estimated completion is 2023-05-18.

What conditions does trial NCT07486895 study?

This clinical trial studies the following conditions: Healthy Adult Participants.

What interventions are being tested in trial NCT07486895?

The interventions under investigation include: Centanafadine (DRUG).

Who is sponsoring clinical trial NCT07486895?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07486895 being conducted?

This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT07486895, the US trial registry maintained by the National Library of Medicine. NCT07486895 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.