clinical trial · NCT05913921
Bioequivalence of Amphotericin B Liposome for Injection
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.·phase1·completed·n = 32
BioequivalenceAmphotericin B liposome for injectionAmBisome
brief summary
The main purpose of this study is to evaluate the bioequivalence of two different amphotericin B liposome for injection after single IV infusion at the same dose in normal healthy subjects.
started
Jun 2, 2023
primary completion
Sep 1, 2023
completion
Sep 1, 2023
last updated
Sep 28, 2023
detailed description
Single-Center, Open-Label, Randomized, Two-treatment, Crossover, Two-sequence, Single-Dose Bioequivalence study of Amphotericin B Liposome for Injection and AmBisome (Amphotericin B) Liposome for Injection in healthy subjects.
official title
A Randomized, Open-label, Single-dose, Two-preparation, Two-period, Two-sequence Bioequivalence Study Between Amphotericin B Liposome for Injection and AmBisome® in Healthy Subjects
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol