NCT05913921

Bioequivalence of Amphotericin B Liposome for Injection

A Randomized, Open-label, Single-dose, Two-preparation, Two-period, Two-sequence Bioequivalence Study Between Amphotericin B Liposome for Injection and AmBisome® in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Single-Center, Open-Label, Randomized, Two-treatment, Crossover, Two-sequence, Single-Dose Bioequivalence study of Amphotericin B Liposome for Injection and AmBisome (Amphotericin B) Liposome for Injection in healthy subjects.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Amphotericin B liposome for injection	IV infusion, 2.0 mg/kg
DRUG	AmBisome	IV infusion, 2.0 mg/kg

Timeline

• Start date: 2023-06-02
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2023-06-22
• Last updated: 2023-09-28

Locations

1 site across 1 country: China