NCT06461078

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Il-Yang Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-07-22
• Primary completion: 2024-09-25
• Completion: 2025-04-28
• First posted: 2024-06-14
• Last updated: 2025-04-30

Locations

1 site across 1 country: South Korea