A Trial to Compare the Amount of Centanafadine That Enters the Bloodstream for Two Different Formulations of Centanafadine
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
The purpose of this trial is to assess relative bioavailability of centanafadine (CTN) SR tablet to CTN QD XR capsule in healthy adult participants.
Key facts
- Study ID
- NCT07465731
- Run by
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- People needed
- 62
- Starts
- 2022-10-27
- Expected to finish
- 2023-03-26
- Last updated by the study team
- 2026-03-12
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Body mass index from 19.0 to 32.0 kilograms per square meter (kg/m\^2) (inclusive).
- In good health as determined by:
- Medical history
- Physical examination
- Electrocardiogram (ECG)
- Serum/urine chemistry, hematology, and serology tests.
- Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
You may not qualify if…
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving investigational medicinal product (IMP).
- Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
- Consumption of alcohol and/or food and beverages containing caffeine, methylxanthines (e.g., coffee, chocolate) within 72 hours prior to dosing.
- History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen and/or hepatitis C antibodies, or human immunodeficiency virus antibodies.
- History of any significant drug allergy or known or suspected hypersensitivity.
- Any participant who, in the opinion of the investigator, should not participate in the trial.
Where it is running
- ICON, plc., — Lenexa, Kansas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.