A Randomized, Open-label, Two-preparation, Single-dose, Two-sequence Pilot Bioequivalence Study Between Amphotericin B Liposome for Injection and AmBisome® in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Bioequivalence based on Cmax
研究概览
简要总结
The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different amphotericin B liposome for injection after single IV infusion at the same dose in normal healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects fully understand and voluntarily participate in this study and sign informed consent.
- •Healthy female and male volunteers aged 18-55 years.
- •Body weight ≥ 50 kg for male and ≥ 45 kg for female with a body mass index (BMI) in the range of 19.0 to 26.0 kg/m2 (inclusive).
- •Subjects must be in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
- •Able to communicate well with the investigator and comply with the requirements of the study.
排除标准
- •History of allergic reactions to amphotericin B or its analogs. History of allergy to two or more kinds of drugs or food.
- •Subjects have any history of surgery, trauma that may affect the safety of the study or the intracorporal process of the drug, or have a surgical schedule during the study period.
- •Use of any prescription or over the counter medication within 14 days prior to screening.
- •History of drug abuse within 6 months prior to screening.
- •Smoking more than 5 cigarettes per day within 3 months prior to screening, or unable to stop using any tobacco products during the trial period.
- •Consumption of alcohol in excess of 14 units/week within 3 months prior to screening.
- •Consumption excessive amounts of tea, coffee and/or caffeine-rich beverages daily within 3 months prior to screening.
- •Participation in other trial within 3 months prior to screening.
- •Donation or loss of more than 400 mL blood within 3 months prior to screening.
- •Subject (female) is lactating or pregnant.
- •Subject who cannot tolerate venipuncture or have a history of needle and blood sickness.
- •Subject who has special requirements on diet and cannot accept the uniform diet.
- •Subject who has childbearing plan, unwillingness or inability to use effective contraceptives from 2 weeks before the screening to 6 months after the last dosing of the study drug.
- •Any positive test result for Hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti-syphilis spirochete.
- •Female subjects with positive pregnancy test results during the screening period or during the study.
- •Positive test result for alcohol screening or drug abuse.
- •AST or ALT, total or direct bilirubin, alkaline phosphatase and creatinine are above the upper limit of normal and potassium is below the lower limit of normal; any other abnormalities in laboratory tests and ancillary tests that are judged by the investigator to be clinically significant.
- •Not suitable for this study as determined by the investigator due to other reasons.
研究组 & 干预措施
Sequence TR
6 healthy subjects assigned to the sequence TR were administrated intravenously for 120 mins with the test product of amphotericin B liposome for injection in period 1 and the reference product of AmBisome® in period 2.
干预措施: Amphotericin B liposome for injection (Drug)
Sequence TR
6 healthy subjects assigned to the sequence TR were administrated intravenously for 120 mins with the test product of amphotericin B liposome for injection in period 1 and the reference product of AmBisome® in period 2.
干预措施: AmBisome® (Drug)
Sequence RT
6 healthy subjects assigned to the sequence RT were administrated intravenously for 120 mins with the reference product of AmBisome® in period 1 and the test product of amphotericin B liposome for injection in period 2.
干预措施: Amphotericin B liposome for injection (Drug)
Sequence RT
6 healthy subjects assigned to the sequence RT were administrated intravenously for 120 mins with the reference product of AmBisome® in period 1 and the test product of amphotericin B liposome for injection in period 2.
干预措施: AmBisome® (Drug)
结局指标
主要结局
Bioequivalence based on Cmax
时间窗: predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion
90% CI of Cmax of liposome-encapsulated and non-liposome-encapsulated Amphotericin B between Amphotericin B liposome for injection and AmBisome® within 80.00%\~125.00%.
Bioequivalence based on AUC0-t
时间窗: predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion
90% CI of AUC0-t of liposome-encapsulated andnon-liposome-encapsulated Amphotericin B between Amphotericin B liposome for injection and AmBisome® within 80.00%\~125.00%.
Bioequivalence based on AUCinf
时间窗: predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion
90% CI of AUC0-∞ of liposome-encapsulated and non-liposome-encapsulated Amphotericin B between Amphotericin B liposome for injection and AmBisome® within 80.00%\~125.00%.
次要结局
- Tmax of liposome-encapsulated and non-liposome-encapsulated Amphotericin B(predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion)
- t1/2 of liposome-encapsulated and non-liposome-encapsulated Amphotericin B(predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion)
- λz of liposome-encapsulated and non-liposome-encapsulated Amphotericin B(predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion)
- Residual area of liposome-encapsulated and non-liposome-encapsulated Amphotericin B(predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion)
- Number of treatment-emergent adverse events for the test and the reference products(predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion)