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COMPLETED
NCT06977490
NA

Human Bioequivalence Study of Amphotericin B Liposome for Injection

Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2025-05-13

Completion Date

2025-10-07

Last Updated

2026-05-22

Healthy Volunteers

Yes

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.

Locations (1)

Jinan Central Hospital, No.105, Jiefang Road,

Jinan, Shandong, China