U.S., May 22 -- ClinicalTrials.gov registry received information related to the study (NCT06983665) titled 'Human Bioequivalence Study of Liposomal Amphotericin B for Injection' on May 06.
Brief Summary: A single-center, randomized, open-label, single-dose, two-period, double-crossover study to evaluate the bioequivalence of liposomal amphotericin B for injection (test product) manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd. compared to the reference product (AmBisome(R)) in healthy Chinese subjects. Secondary objectives include safety evaluation.
Study Start Date: May, 2025
Study Type: INTERVENTIONAL
Condition:
Invasive Fungal Infections
Neutropenic Fever
Visceral Leishmaniasis
Intervention:
DRUG: Test product (Liposomal amph...