Trials / Completed
CompletedNCT07486895
Trial to Demonstrate the Equivalence of Two Different Strengths of Oral Centanafadine Capsules in Healthy Subjects
An Open-label, Randomized, Crossover Trial in Healthy Subjects to Assess Dose Strength Equivalence Among 164.4 and 328.8 mg Strengths of Oral Centanafadine QD XR Capsules
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 44 (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 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Centanafadine | Centanafadine will be administered as an oral capsule. |
Timeline
- Start date
- 2023-03-08
- Primary completion
- 2023-05-18
- Completion
- 2023-05-18
- First posted
- 2026-03-23
- Last updated
- 2026-03-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07486895. Inclusion in this directory is not an endorsement.