drugset

drugset / Trial / NCT04675528

Food Effect on Pharmacokinetics and Safety of DHP107 (Liporaxel®) FEEL Study

NCT04675528 ↗

Phase 1 Completed 25 enrolled Daehwa Pharmaceutical Co., Ltd.

RandomizedCrossoverOpen-labelTreatment

Summary

To evaluate the food effect on pharmacokinetics of DHP107 in patients with advanced solid tumors.

Timeline

Start: 2021-05-04
Primary completion: 2022-12-12
Completion: 2022-12-12

Outcome

Met primary endpoint

paper AUC0-inf 104.76% (95% CI 96.44-113.80%), meeting criteria for no food effect. PMID 42215716 ↗

paper Mean systemic exposures were similar for paclitaxel and its metabolites under fed and fasted conditions. PMID 42215716 ↗

Publications

Hitre E, Lang I, Pall D. A randomized, open-label, two-way crossover clinical trial to evaluate the food effect on pharmacokinetics and safety of DHP107 in patients with advanced solid tumors: the FEEL study. Cancer Chemother Pharmacol. 2026 May 30;96(1):59. doi: 10.1007/s00280-026-04887-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paclitaxel	Small molecule	200 mg/m2	Oral

Indications