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Bioequivalence of Amphotericin B Liposome for Injection

NCT05913921 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-09-28

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the bioequivalence of two different amphotericin B liposome for injection after single IV infusion at the same dose in normal healthy subjects.

Conditions

  • Bioequivalence

Interventions

DRUG

Amphotericin B liposome for injection

IV infusion, 2.0 mg/kg

DRUG

AmBisome

IV infusion, 2.0 mg/kg

Sponsors & Collaborators

  • CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • XiaoAi He · Haikou People's 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
2023-06-02
Primary Completion
2023-09-01
Completion
2023-09-01

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 NCT05913921 on ClinicalTrials.gov