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NCT07253441 · ClinicalTrials.gov registry record · Phase 1
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 Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 1
- Development phase
- 174
- Enrollment target
NCT07253441: Completed Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT07253441 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 174 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (190% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07253441, a Phase 1 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 174 participants
- Enrollment target
Study 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.
Interventions
- DRUG CTN SR
- DRUG CTN XR (TBM)
- DRUG CTN XR (Clin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2024-08-29 |
| Est. Completion | 2024-12-30 |
| Phase | Phase 1 |
What the finished NCT07253441 record still lists
NCT07253441 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (190% higher).
The record links to 0 conditions, and to 3 interventions - of which CTN SR is the first listed.
NCT07253441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07253441 about?
NCT07253441 is a clinical study titled "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". 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 ...
What is the current status of trial NCT07253441?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 174 participants. The study started on 2024-08-29. Estimated completion is 2024-12-30.
What interventions are being tested in trial NCT07253441?
The interventions under investigation include: CTN SR (DRUG), CTN XR (TBM) (DRUG), CTN XR (Clin) (DRUG).
Who is sponsoring clinical trial NCT07253441?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07253441's enrollment target sits among peer trials
174 322nd of 2000 higher than 1,677 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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