A Randomized, Open-label, Single-dose, Two-preparation, Two-period, Two-sequence Bioequivalence Study Between Amphotericin B Liposome for Injection and AmBisome® in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Amphotericin B liposome for injection
- Conditions
- Bioequivalence
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Bioequivalence based on Cmax
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The main purpose of this 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.
Detailed Description
Single-Center, Open-Label, Randomized, Two-treatment, Crossover, Two-sequence, Single-Dose Bioequivalence study of Amphotericin B Liposome for Injection and AmBisome (Amphotericin B) Liposome for Injection in healthy subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must give informed consent before the trial, fully understand the content, process and possible adverse reactions, and voluntarily sign a written informed consent.
- •The subjects can communicate well with the investigators and complete the trial according to protocol.
- •Sex: male or female subjects.
- •Age of 18 - 55 years (inclusive).
- •BMI: 18.6-28.5 kg/m\^2 (inclusive), with a minimum weight of 50 kg (inclusive) for males and 45 kg (inclusive) for females.
Exclusion Criteria
- •Allergic constitution, or known history of allergy to the components of the study drug or similar drugs.
- •Subjects with the following diseases of clinical significance (including but not limited to diseased related to respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, psychiatric system, otorhinolaryngology).
- •Subjects with liver and kidney diseases that affect the pharmacokinetic of drugs.
- •Those who underwent major surgery within 6 months prior to initial administration, or who planned to undergo surgery during the study.
- •Clinically significant abnormalities in vital signs, physical examination, electrocardiogram and laboratory examination (including but not limited to alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and creatinine above the upper limit of normal).
- •Subjects with a history of hepatitis B, hepatitis C, AIDS, syphilis and/or abnormalities in one or more of the four tests for infectious diseases with clinical significance.
- •Blood loss or blood donation of more than 200 mL within 3 months prior to initial administration (except for female menstrual period), and/or platelet donation within 2 weeks prior to initial administration.
- •Use of any drug within 14 days prior to initial administration (except for topical drugs with local effects).
- •Use of any investigational medicinal product within 3 months prior to initial administration.
- •A history of drug abuse, and/or drug use within 3 months prior to screening, and/or habitual use of any drug, including Chinese herbs.
Arms & Interventions
Sequence TR
16 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
Intervention: Amphotericin B liposome for injection
Sequence TR
16 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
Intervention: AmBisome
Sequence RT
16 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
Intervention: Amphotericin B liposome for injection
Sequence RT
16 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
Intervention: AmBisome
Outcomes
Primary Outcomes
Bioequivalence based on Cmax
Time Frame: predose to 216 hours post dose
90% CI of Cmax of liposome-encapsulated Amphotericin B between Amphotericin B liposome for injection and AmBisome® within 80.00%\~125.00%
Bioequivalence based on AUC0-t
Time Frame: predose to 216 hours post dose
90% CI of AUC0-t of liposome-encapsulated Amphotericin B between Amphotericin B liposome for injection and AmBisome® within 80.00%\~125.00%
Bioequivalence based on AUCinf
Time Frame: predose to 216 hours post dose
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%
Secondary Outcomes
- AUC0-∞(predose to 216 hours post dose)
- Cmax(predose to 216 hours post dose)
- AUC0-t(predose to 216 hours post dose)