Human Bioequivalence Study of Liposomal Amphotericin B for Injection (NCT06983665) | Clinical Trial Compass
CompletedNot Applicable
Human Bioequivalence Study of Liposomal Amphotericin B for Injection
China58 participantsStarted 2025-05-25
Plain-language summary
A single-center, randomized, open-label, single-dose, two-period, double-crossover study to evaluate the bioequivalence of liposomal amphotericin B for injection (test product) manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd. compared to the reference product (AmBisome®) in healthy Chinese subjects. Secondary objectives include safety evaluation.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntary participate in the clinical trial, with the ability to sign an informed consent form (ICF) and have a full understanding of trial contents, process, and potential adverse reactions, and be able to understand and adhere to the trial procedures;
. Chinese male and female subjects aged 18 to 55 years old (inclusive);
. Male subjects with weight no less than 50.0 kg, and female subjects with weight no less than 45.0 kg. Body mass index (BMI) = weight/height2 (kg/m2). BMI is 18.6-28.5 kg/m2 (both inclusive);
. At screening, subjects' vital signs, physical examinations, laboratory tests, and electrocardiogram (ECG) results are normal, or abnormal but clinically insignificant as determined by the Investigator;
. Subjects (including male subjects) have adopted effective contraceptive measures within 14 days prior to the first dosing and are willing to refrain from pregnancy, donating sperm or eggs, and voluntarily use effective contraceptive measures (non-pharmacological contraception during the trial) from the time of signing the informed consent form until 6 months after the last dose.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bioequivalence based on Cmax of liposome-encapsulated
Timeframe: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
2
Bioequivalence based on AUC0-t of liposome-encapsulated
Timeframe: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
3
Bioequivalence based on AUC0-∞ of liposome-encapsulated
Timeframe: 0 h before safe dose and 0 h before formal dose to 1320 hours post formal dose
. Subjects with chronic or severe diseases of the cardiovascular, hepatic, renal, respiratory, hematological and lymphatic, endocrine, immune, mental and nervous, gastrointestinal, metabolic, and skeletal systems, who, as determined by the Investigator, are not suitable to participate in the study;
. Subjects with clinically significant abnormalities as determined by the Investigator, including physical examination, vital signs, ECG or clinical laboratory tests, especially abnormalities in hepatic and renal functions (subjects with serum creatinine, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) above the upper limit of normal (ULN));
. Subjects with existing allergic diseases (nettle rash, eczema, etc.), or an atopic constitution (e.g. allergies to two or more medications, foods such as milk, or pollen), or a known history of hypersensitivity to any component of conventional amphotericin B formulations or liposomal amphotericin B formulations, including the active ingredient or any excipients in this product (such as soybean oil), peanuts or soy;
. Subjects who are positive for any one or more of the following tests: Hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody, Treponema pallidum specific antibody and human immunodeficiency virus (HIV) antigen/antibody;
. Subjects with a history of drug abuse;
. Subjects who are positive for urine drug screening (methamphetamine (meth), MDMA (ecstasy), THC (cannabis), morphine, ketamine);
. Regular drinkers within 3 months prior to screening, defined as subjects who drink more than 14 units of alcohol per week (1 unit ≈ 285 mL of beer with 3.5% ABV or 25 mL of spirits with 40% ABV or 85 mL of wine with 10% ABV), or subjects who cannot stop drinking or consuming any alcoholic products throughout the study;
. Subjects who are positive for breath alcohol test;