Human Bioequivalence Study of Amphotericin B Liposome for Injection

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
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⁃ The enrolled participants shall meet all of the following criteria:

• The study participants must give informed consent before the trial, fully understand the content, process and possible adverse reactions, and voluntarily sign a written informed consent;

• The study participants can communicate well with the investigators and complete the trial according to protocol;

• Sex: female or male; age: 18-50 years (inclusive);

• Body Mass Index (BMI): 19-28 kg/m2 (inclusive), with a minimum weight of 50.0 kg for males and 45.0 kg for females (BMI = Body weight / Height2 \[kg/m2\]).

Locations
Other Locations
China
Jinan Central Hospital, No.105, Jiefang Road,
RECRUITING
Jinan
Contact Information
Primary
Qing Wen
zxyyyxll@126.com
13370551767
Time Frame
Start Date: 2025-05-13
Estimated Completion Date: 2025-10-07
Participants
Target number of participants: 42
Treatments
Experimental: Amphotericin B Liposome for Injection (Sichuan Huiyu Pharmaceutical Co., Ltd.)
* Amphotericin B Liposome for Injection (strength: 50 mg, Sichuan Huiyu Pharmaceutical Co., Ltd.)~* The test product
Experimental: Amphotericin B Liposome for Injection (trade name: Ambisome®)
* Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences)~* The reference product
Related Therapeutic Areas
Sponsors
Collaborators: Changsha King-eagle Med Technology Co., Ltd.
Leads: Sichuan Huiyu Pharmaceutical Co., Ltd

This content was sourced from clinicaltrials.gov