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Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics and Safety of Orally Administered Radotinib

NCT06461078 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-04-30

No results posted yet for this study

Summary

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics and Safety of Orally Administered Radotinib in Healthy Adults

Conditions

  • Drug Kinetics

Interventions

DRUG

Radotinib HCl

1. Brand name/manufacturer: Supect Cap./IL-YANG PHARM. Co., Ltd. 2. Active ingredient: radotinib HCl 106.8mg (100mg as radotinib) or HCl 213.6mg (200mg as radotinib) 3. Appearance and formulation: hard capsule with a light blue cap and a body containing pale yellow powder 4. Storage conditions: Store in an airtight light proof container at room temperature.

Sponsors & Collaborators

  • Il-Yang Pharm. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Minsoo Park, PhD · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-22
Primary Completion
2024-09-25
Completion
2025-04-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06461078 on ClinicalTrials.gov