clinical trial · NCT06977490
Human Bioequivalence Study of Amphotericin B Liposome for Injection
Sichuan Huiyu Pharmaceutical Co., Ltd·N/A·completed·n = 42
Invasive Fungal InfectionsNeutropenic FeverVisceral LeishmaniasisAmphotericin B Liposome for Injection (strength: 50 mg, Sichuan Huiyu Pharmaceutical Co., Ltd.)Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences)
brief summary
Single-center, randomized, open-label, single-dose, two-treatment, two-period, two-sequence crossover design to evaluate the human bioequivalence of two Amphotericin B Liposome for Injection formulations
started
May 13, 2025
primary completion
Oct 7, 2025
completion
Oct 7, 2025
last updated
Nov 25, 2025
detailed description
To evaluate the human bioequivalence of Amphotericin B Liposome for Injection (strength: 50 mg) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences) by comparing the differences in the extent and rate of absorption between the two formulations in a healthy Chinese population under a single-center, randomized, open-label, single-dose, two-treatment, two-period, two-sequence crossover design.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol