Invasive Fungal InfectionsNCT06977490
Human Bioequivalence Study of Amphotericin B Liposome for Injection
A study testing Amphotericin B Liposome for Injection (strength: 50 mg, Sichuan Huiyu Pharmaceutical Co., Ltd.) and Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences) in people with Invasive Fungal Infections and Neutropenic Fever, run by Sichuan Huiyu Pharmaceutical Co., Ltd at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Invasive Fungal Infections, Neutropenic Fever, Visceral Leishmaniasis
- What is being tested?
- Amphotericin B Liposome for Injection (strength: 50 mg, Sichuan Huiyu Pharmaceutical Co., Ltd.) and Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2025to 7 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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]).
Who cannot join
- 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)
Show all 23Show fewer
- 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;
- Subjects who consume excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day within 6 months prior to screening, and/or do not agree that tea, coffee and/or caffeinated foods, grapefruit and/or grapefruit juice, and/or products containing opium poppy are prohibited 48 h prior to initial administration and during the trial; (inquiry)
- Subjects who have a birth plan (including sperm or egg donation) and/or do not agree to take effective contraceptive methods (non-drug during the trial period) from signing informed consent form to 6 months after the final administration; (inquiry)
- Pregnant or lactating women or subjects with positive pregnancy results; (inquiry, for females only)
- Subjects who have used oral contraceptives within 30 days prior to initial administration; (inquiry)
- Use of long-acting estrogen and/or progesterone injections and/or implants within 6 months prior to initial administration; (inquiry, females only)
- Women of childbearing age who have unprotected sex with their partner within 14 days prior to initial administration; (inquiry, females only)
- Subjects who cannot tolerate venipuncture or have a history of needle and blood sickness; (inquiry)
- Subjects who may not be able to complete the study for other reasons or who the investigator considers should not be included.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Being tested
- Amphotericin B Liposome for Injection (strength: 50 mg, Sichuan Huiyu Pharmaceutical Co., Ltd.), Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences)
- Medical subject headings
- Invasive Fungal Infections, Febrile Neutropenia, Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphotericin B Liposome for Injection (strength: 50 mg, Sichuan Huiyu Pharmaceutical Co., Ltd.)Drug
Also called The test product
Single intravenous administration of 3.0 mg/kg in each period.
Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences)Drug
Also called The reference product
Single intravenous administration of 3.0 mg/kg in each period.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
90% confidence interval is within the 80.00%-125.00% equivalence margin.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0 hour before safe dose and 0 hour before formal dose to 1320 hours post formal dose
Secondary outcomes (4)
Tmax
90% confidence intervals will also be investigated as supportive data.
Measured: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
λz
90% confidence intervals will also be investigated as supportive data.
Measured: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
t1/2
90% confidence intervals will also be investigated as supportive data.
Measured: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
AUC_%Extrap
90% confidence intervals will also be investigated as supportive data.
Measured: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start13 May 2025
- Primary completion7 Oct 2025
- Study completion7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionsStudies of the same condition, open and under way.
- More trials run by Sichuan Huiyu Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Changsha King-eagle Med Technology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Qing Wen, Study director, Jinan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977490
- Sponsor's protocol ID
- JY-BE-AMB-2024-120
- Status last verified
- May 2026
- First submitted
- 30 Apr 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Bioequivalence Study of Amphotericin B Liposome for Injection
- ClinicalTrials.gov ID
- NCT06977490
- Acronym / sponsor ID
- JY-BE-AMB-2024-120
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Sichuan Huiyu Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Changsha King-eagle Med Technology Co., Ltd.
- Study start
- 13 May 2025 (actual)
- Primary completion
- 7 Oct 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amphotericin B Liposome for Injection (Sichuan Huiyu Pharmaceutical Co., Ltd.) | Experimental | Drug: Amphotericin B Liposome for Injection (strength: 50 mg, Sichuan Huiyu Pharmaceutical Co., Ltd.)* Amphotericin B Liposome for Injection (strength: 50 mg, Sichuan Huiyu Pharmaceutical Co., Ltd.) * The test product |
| Amphotericin B Liposome for Injection (trade name: Ambisome®) | Experimental | Drug: Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences)* Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences) * The reference product |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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]).
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amphotericin B Liposome for Injection (strength: 50 mg, Sichuan Huiyu Pharmaceutical Co., Ltd.)Also: The test productSingle intravenous administration of 3.0 mg/kg in each period. | Drug | Amphotericin B Liposome for Injection (Sichuan Huiyu Pharmaceutical Co., Ltd.) |
| Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences)Also: The reference productSingle intravenous administration of 3.0 mg/kg in each period. | Drug | Amphotericin B Liposome for Injection (trade name: Ambisome®) |
Primary outcome
Cmax
Time frame: 0 hour before safe dose and 0 hour before formal dose to 1320 hours post formal dose
90% confidence interval is within the 80.00%-125.00% equivalence margin.
AUC0-t
Time frame: 0 hour before safe dose and 0 hour before formal dose to 1320 hours post formal dose
90% confidence interval is within the 80.00%-125.00% equivalence margin.
AUC0-∞
Time frame: 0 hour before safe dose and 0 hour before formal dose to 1320 hours post formal dose
90% confidence interval is within the 80.00%-125.00% equivalence margin.
AUC0-10h
Time frame: 0 hour before safe dose and 0 hour before formal dose to 1320 hours post formal dose
90% confidence interval is within the 80.00%-125.00% equivalence margin.
AUC10-last
Time frame: 0 hour before safe dose and 0 hour before formal dose to 1320 hours post formal dose
90% confidence interval is within the 80.00%-125.00% equivalence margin.
4 secondary outcomes
Tmax
Time frame: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
λz
Time frame: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
t1/2
Time frame: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
AUC_%Extrap
Time frame: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
Related trials for Invasive Fungal Infections
RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children and Adults
Invasive Candidiasis
RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
Invasive Mold Infections
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Wen study director
Jinan Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amphotericin B Liposome for Injection (strength: 50 mg, Sichuan Huiyu Pharmaceutical Co., Ltd.) and Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences) in people with Invasive Fungal Infections and Neutropenic Fever, run by Sichuan Huiyu Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 0 hour before safe dose and 0 hour before formal dose to 1320 hours post formal dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.