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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 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 174 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07253441
The ClinicalTrials.gov registry entry for NCT07253441 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which CTN SR is the first listed.
NCT07253441 reports 0 study locations.
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.
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