NCT06983665

Human Bioequivalence Study of Liposomal Amphotericin B for Injection

Single-Dose, Randomized, Open-Label, Two-Sequence, Two-Period, Double-Crossover, Bioequivalence Study of Liposomal Amphotericin B for Injection in Healthy Chinese Subjects

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study involves 42 healthy subjects (male and female) aged 18-55 years. Subjects will be randomized into two groups (TR and RT) and receive either the test or reference product in period 1, followed by a 92-day washout period before crossing over to the other product in period 2. Blood samples will be collected at 25 time points for pharmacokinetic analysis.

Conditions

• Invasive Fungal Infections
• Neutropenic Fever
• Visceral Leishmaniasis

Interventions

Type	Name	Description
DRUG	Test product (Liposomal amphotericin B for injection, Sichuan Huiyu Pharmaceutical Co., Ltd.)	Single intravenous administration of 2.0 mg/kg in each period.
DRUG	Reference product (AmBisome®, Astellas Pharma US Inc.)	Single intravenous administration of 2.0 mg/kg in each period.

Timeline

• Start date: 2025-05-25
• Primary completion: 2025-11-10
• Completion: 2026-04-01
• First posted: 2025-05-21
• Last updated: 2026-03-23

Locations

1 site across 1 country: China