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Human Bioequivalence Study of Amphotericin B Liposome for Injection

NCT06977490 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-05-22

No results posted yet for this study

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

Conditions

  • Invasive Fungal Infections
  • Neutropenic Fever
  • Visceral Leishmaniasis

Interventions

DRUG

Amphotericin B Liposome for Injection (strength: 50 mg, Sichuan Huiyu Pharmaceutical Co., Ltd.)

Single intravenous administration of 3.0 mg/kg in each period.

DRUG

Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences)

Single intravenous administration of 3.0 mg/kg in each period.

Sponsors & Collaborators

  • Changsha King-eagle Med Technology Co., Ltd.

    collaborator UNKNOWN

  • 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
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-13
Primary Completion
2025-10-07
Completion
2025-10-07

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 NCT06977490 on ClinicalTrials.gov