Human Bioequivalence Study of Amphotericin B Liposome for Injection

NCT06977490 | Completed

• 1 other identifier: JY-BE-AMB-2024-120
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Invasive Fungal Infections; Neutropenic Fever; Visceral Leishmaniasis

Outcome Measures

Primary Outcomes (5)

• Cmax

  90% confidence interval is within the 80.00%-125.00% equivalence margin.

  0 hour before safe dose and 0 hour before formal dose to 1320 hours post formal dose

• AUC0-t

  90% confidence interval is within the 80.00%-125.00% equivalence margin.

  0 hour before safe dose and 0 hour before formal dose to 1320 hours post formal dose

• AUC0-∞

  90% confidence interval is within the 80.00%-125.00% equivalence margin.

  0 hour before safe dose and 0 hour before formal dose to 1320 hours post formal dose

• AUC0-10h

  90% confidence interval is within the 80.00%-125.00% equivalence margin.

  0 hour before safe dose and 0 hour before formal dose to 1320 hours post formal dose

• AUC10-last

  90% confidence interval is within the 80.00%-125.00% equivalence margin.

  0 hour before safe dose and 0 hour before formal dose to 1320 hours post formal dose

Secondary Outcomes (4)

• Tmax

  0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose

• λz

  0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose

• t1/2

  0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose

• AUC_%Extrap

  0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose

Study Arms (2)

Amphotericin B Liposome for Injection (Sichuan Huiyu Pharmaceutical Co., Ltd.)

EXPERIMENTAL

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

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

Amphotericin B Liposome for Injection (trade name: Ambisome®)

EXPERIMENTAL

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

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

Interventions

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

Single intravenous administration of 3.0 mg/kg in each period.

Also known as: The test product

Amphotericin B Liposome for Injection (Sichuan Huiyu Pharmaceutical Co., Ltd.)

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

Single intravenous administration of 3.0 mg/kg in each period.

Also known as: The reference product

Amphotericin B Liposome for Injection (trade name: Ambisome®)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \[kg/m2\]).

You may not qualify if:

• Study participants meeting one or more of the following criteria will be excluded:
• 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)
• 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)
• Subjects with gastrointestinal, liver and kidney diseases that affect the pharmacokinetics of drugs; (inquiry)
• Subjects who underwent major surgery within 6 months prior to initial administration, or who planned to undergo surgery during the study; (inquiry)
• Clinically significant abnormalities in vital signs, physical examination, electrocardiogram and laboratory tests (blood biochemistry, hematology, urinalysis, coagulation); (as determined by the clinical investigator)
• 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)
• 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)
• 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)
• 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)
• Subjects who received vaccines or live attenuated vaccines within 4 weeks prior to the administration of the study drug, or who planned to be vaccinated during the trial; (inquiry)
• Subjects who received medication in any clinical trial or participated in any medical device clinical trial within 3 months prior to initial administration; (inquiry + online screening)
• A history of drug abuse within 5 years, and/or drug use within 3 months prior to screening, and/or habitual use of any drug (including Chinese herbs) or positive urine drug screening; (inquiry + as determined by the clinical investigator)
• Subjects who smoked more than 5 cigarettes per day within 3 months prior to screening and/or did not agree to refrain from using any tobacco products during the trial; (inquiry)
• Regular drinkers within 6 months prior to screening, i.e., subjects who drank more than 14 units of alcohol per week (1 unit = 360 mL of beer with 5% alcohol or 45 mL of spirits with 40% alcohol or 150 mL of wine with 12% alcohol), or subjects who did not agree to stop drinking alcohol 48 h prior to initial administration and during the trial, or test positive for breath alcohol;

Sponsors & Collaborators

• Sichuan Huiyu Pharmaceutical Co., Ltd: lead
• Changsha King-eagle Med Technology Co., Ltd.: collaborator

Study Sites (1)

Jinan Central Hospital, No.105, Jiefang Road,

Jinan, Shandong, China

Location

MeSH Terms

Conditions

Invasive Fungal Infections; Febrile Neutropenia; Leishmaniasis, Visceral

Interventions

Amphotericin B; Injections; Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Drug Administration Routes; Drug Therapy; Therapeutics; Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Qing Wen

  Jinan Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 18, 2025
• Study Start: May 13, 2025
• Primary Completion: October 7, 2025
• Study Completion: October 7, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)