Human Bioequivalence Study of Amphotericin B Liposome for Injection

NARecruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

May 13, 2025

Primary Completion Date

October 7, 2025

Study Completion Date

October 7, 2025

Conditions
Invasive Fungal InfectionsNeutropenic FeverVisceral 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.

Trial Locations (1)

Unknown

RECRUITING

Jinan Central Hospital, No.105, Jiefang Road,, Jinan

All Listed Sponsors
collaborator

Changsha King-eagle Med Technology Co., Ltd.

UNKNOWN

lead

Sichuan Huiyu Pharmaceutical Co., Ltd

INDUSTRY