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

Part of paid clinical trials in Lenexa, Kansas.

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study ID
NCT07486895
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Adult Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Centanafadine — DRUG
    Centanafadine will be administered as an oral capsule.

Study Details

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.

Key Dates

Start date
Mar 8, 2023
Status verified
Mar 2026
Primary completion
May 18, 2023
Completion
May 18, 2023

Study Design

Enrollment
44 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: CTN 1 x 328.8 mg QD XR, Then CTN 2 x 164.4 mg QD XR
    Participants will first receive 1 × 328.8 mg centanafadine QD XR capsule orally on Day 1, followed by 2 × 164.4 mg centanafadine QD XR capsules administered orally once daily on Day 5.
  • Experimental: CTN 2 x 164.4 mg QD XR, Then CTN 1 x 328.8 mg QD XR
    Participants will first receive 2 × 164.4 mg centanafadine QD XR capsule, orally on Day 1. Then, they will receive 1 × 328.8 mg centanafadine QD XR capsule orally on Day 5.

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) of Centanafadine [ Time Frame: Up to Day 5 ]

Locations (1)

FacilityCityStateZIPSite coordinators
ICON plcLenexaKansas66219-

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By research site
ICON plc· Lenexa, KS

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