Human Bioequivalence Study of Liposomal Amphotericin B for Injection (NCT06983665) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Human Bioequivalence Study of Liposomal Amphotericin B for Injection
China42 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 range18 Years – 55 Years
SexALL
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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.
Exclusion criteria
✕. 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));
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 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;