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Human Bioequivalence Study of Amphotericin B Liposome for Injection | Clinical Trials | Clareo Health

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Human Bioequivalence Study of Amphotericin B Liposome for Injection

NCT06977490•Sichuan Huiyu Pharmaceutical Co., Ltd

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•The enrolled participants shall meet all of the following criteria:
•1. 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;
•2. The study participants can communicate well with the investigators and complete the trial according to protocol;
•3. Sex: female or male; age: 18-50 years (inclusive);
•4. 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 \[kg/m2\]).

Exclusion Criteria

•Study participants meeting one or more of the following criteria will be excluded:
•1. Allergic constitution (such as those allergic to two or more drugs or foods \[e.g., milk\], or pollen), or known history of allergy to the components of the study drug or similar drugs (API: amphotericin B; excipients: hydrogenated soy phosphatidylcholine, cholesterol, distearoylphosphatidylglycerol \[sodium salt\], alpha tocopherol, sucrose, disodium succinate hexahydrate, hydrochloric acid, and sodium hydroxide); (inquiry)
•2. Subjects with the following diseases of clinical significance (including but not limited to diseases related to respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, psycho-neurological system, ophthalmology and otorhinolaryngology); (inquiry)
•3. Subjects with gastrointestinal, liver and kidney diseases that affect the pharmacokinetics of drugs; (inquiry)
•4. Subjects who underwent major surgery within 6 months prior to initial administration, or who planned to undergo surgery during the study; (inquiry)
•5. Clinically significant abnormalities in vital signs, physical examination, electrocardiogram and laboratory tests (blood biochemistry, hematology, urinalysis, coagulation); (as determined by the clinical investigator)
•6. Subjects with a history of hepatitis B, hepatitis C, AIDS (Acquired Immune Deficiency Syndrome), syphilis and/or abnormalities in one or more of the four tests for infectious diseases with clinical significance; (as determined by the clinical investigator)
•7. Blood loss or blood donation of greater than or equal to 400 mL within 3 months prior to initial administration (except for female menstrual period), and/or platelet donation within 2 weeks prior to initial administration; (inquiry)
•8. Use of any prescription medicine within 14 days prior to initial administration or use of any over-the-counter medicine, Chinese herbal medicine or health product within 7 days prior to initial administration (except for topical drugs with local effects); (inquiry)
•9. Use of azoles (e.g., ketoconazole, miconazole, clotrimazole, fluconazole, etc.), skeletal muscle relaxants, corticosteroids and adrenal cortical hormones, antineoplastic agents, digitonin, flucytosine or other nephrotoxic medications within 28 days prior to initial administration; (inquiry)
+13 more criteria

Locations (1)

Jinan Central Hospital, No.105, Jiefang Road,

Jinan, Shandong, China

Key Dates

Start Date

May 13, 2025

Primary Completion Date

October 7, 2025

Completion Date

October 7, 2025

Last Updated

November 25, 2025

Enrollment

ACTUAL participants

Conditions

Invasive Fungal InfectionsNeutropenic FeverVisceral Leishmaniasis

Interventions

Amphotericin B Liposome for Injection (strength: 50 mg, Sichuan Huiyu Pharmaceutical Co., Ltd.)

DRUG

Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences)

DRUG

Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

NCT06105411

Invasive Fungal Infections

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RECRUITINGPHASE4

Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies

NCT07016165

Neutropenic FeverAcute Lymphoblastic Leukemia+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Human Bioequivalence Study of Amphotericin B Liposome for Injection

Inclusion Criteria

Exclusion Criteria

Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies

Breath Analysis for the Detection of Invasive Fungal Infections

Usefulness of PET-CT for Invasive Fungal Infection

L-AmB_ Retrospective mUlticenter Study on Mycosis prOphylaxis

Hyperbaric Oxygen Therapy Used on Severely Injured Healthy Individuals With Fungal Infections