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Human Bioequivalence Study of Liposomal Amphotericin B for Injection

NCT06983665 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-03-23

No results posted yet for this study

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.

Conditions

  • Invasive Fungal Infections
  • Neutropenic Fever
  • Visceral Leishmaniasis

Interventions

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.

Sponsors & Collaborators

  • Sichuan Huiyu Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Qing Wen · Jinan Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-25
Primary Completion
2025-11-10
Completion
2026-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06983665 on ClinicalTrials.gov