drugset

drugset / Trial / NCT05749380

Pharmacokinetics and Safety of AmBisome and DKF-5122

NCT05749380 ↗

Phase 1 Completed 38 enrolled Dongkook Pharmaceutical Co., Ltd.

RandomizedCrossoverOpen-labelOther

Summary

The purpose of the study is to assess the Safety and Pharmacokinetic Characteristics of AmBisome and DKF-5122

Timeline

Start: 2020-09-07
Primary completion: 2022-01-28
Completion: 2022-01-28

Publications

Han S, Yim DS, Han S, Choi S, Cho SY, Lee R, Nho D, Baek HJ, Lee DG. Pharmacokinetic Equivalence of AmphosomTM, a Newly Developed Liposomal Amphotericin B, to AmbisomeⓇ. Clin Ther. 2026 Feb;48(2):186-195. doi: 10.1016/j.clinthera.2025.12.009. Epub 2026 Jan 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amphotericin B	Unknown	3 mg/kg	Intravenous
Subject	DKF-5122	Unknown	3 mg/kg	Intravenous

Indications