NCT06977490

Human Bioequivalence Study of Amphotericin B Liposome for Injection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed description

To evaluate the human bioequivalence of Amphotericin B Liposome for Injection (strength: 50 mg) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences) by comparing the differences in the extent and rate of absorption between the two formulations in a healthy Chinese population under a single-center, randomized, open-label, single-dose, two-treatment, two-period, two-sequence crossover design.

Conditions

• Invasive Fungal Infections
• Neutropenic Fever
• Visceral Leishmaniasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-13
• Primary completion: 2025-10-07
• Completion: 2025-10-07
• First posted: 2025-05-18
• Last updated: 2025-11-25

Locations

1 site across 1 country: China