Clinical Trial

Human Bioequivalence Study of Liposomal Amphotericin B for Injection

Completed
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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®) in healthy Chinese subjects. Secondary objectives include safety evaluation.
Protocol Amendment History 2 changes
critical Trial completed 2026-05-28
notable Enrollment increased: 42 -> 58 participants 2026-05-28
Trial Details
NCT Number NCT06983665
Lead Sponsor Sichuan Huiyu Pharmaceutical Co., Ltd
Conditions Invasive Fungal Infections, Neutropenic Fever, Visceral Leishmaniasis
Enrollment 58 participants
Start Date 2025-05-25
Primary Completion 2025-11-10 (estimated)
Study Completion 2026-03-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-27