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

Phase 1 Completed 24 enrolled Il-Yang Pharm. Co., Ltd.

RandomizedCrossoverOpen-labelTreatment

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

Timeline

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

Publications

Lee Y, Kim J, Kang M, Han J, Kim NY, Shin JS, Park MS, Jiang Q, Lee JI. Clinical pharmacokinetic characteristics and the food effect of radotinib. Invest New Drugs. 2026 Mar 27. doi: 10.1007/s10637-026-01610-6. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Radotinib	Small molecule	200 mg	Oral

Indications

No indication recorded.