Human Bioequivalence Study of Amphotericin B Liposome for Injection (NCT06977490) | Clinical Trial Compass
CompletedNot Applicable
Human Bioequivalence Study of Amphotericin B Liposome for Injection
China42 participantsStarted 2025-05-13
Plain-language 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
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion 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 \[kg/m2\]).
Exclusion criteria
✕. 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)
✕
What they're measuring
1
Cmax
Timeframe: 0 hour before safe dose and 0 hour before formal dose to 1320 hours post formal dose
2
AUC0-t
Timeframe: 0 hour before safe dose and 0 hour before formal dose to 1320 hours post formal dose
3
AUC0-∞
Timeframe: 0 hour before safe dose and 0 hour before formal dose to 1320 hours post formal dose
4
AUC0-10h
Timeframe: 0 hour before safe dose and 0 hour before formal dose to 1320 hours post formal dose
5
AUC10-last
Timeframe: 0 hour before safe dose and 0 hour before formal dose to 1320 hours post formal dose
. 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)