- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05913921
Bioequivalence of Amphotericin B Liposome for Injection
September 27, 2023 updated by: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hainan
-
Haikou, Hainan, China
- Haikou People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
- Positive urine drug screening.
- Those who smoked more than 5 cigarettes per day within 3 months prior to screening and/or did not agree to refrain from using any tobacco products during hospitalization.
- Regular drinkers within 6 months prior to screening, i.e., those who drank more than 14 units of alcohol per week, and/or those who could not stop drinking alcohol during their hospitalization, and/or test positive for breath alcohol.
- Those who consume excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day, and/or do not agree that tea, coffee and/or caffeinated foods, grapefruit (grapefruit) and/or grapefruit juice (grapefruit juice), and/or products containing opium poppy are prohibited during hospitalization.
- Those who have a birth plan (including sperm donation and egg donation) and/or do not agree to take effective contraceptive methods (non-drug during the trial period) within 3 months after signing informed consent form.
Subjects who may not be able to complete the study for other reasons or who the investigator considers should not be included.
In addition to the above requirements, female subjects who meet the following conditions shall also be excluded:
- Pregnant or lactating women or those with positive pregnancy results.
- Those who have used oral contraceptives within 30 days prior to initial administration.
- Use of long-acting estrogen and/or progesterone injections and/or implants within 6 months prior to initial administration.
- Women of childbearing age who have unprotected sex with their partner within 14 days prior to initial administration.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
IV infusion, 2.0 mg/kg
Other Names:
IV infusion, 2.0 mg/kg
Other Names:
|
Experimental: 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
|
IV infusion, 2.0 mg/kg
Other Names:
IV infusion, 2.0 mg/kg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%
|
predose to 216 hours post dose
|
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%
|
predose to 216 hours post dose
|
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%
|
predose to 216 hours post dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: predose to 216 hours post dose
|
90% CI of Cmax of non-liposome-encapsulated and total Amphotericin B
|
predose to 216 hours post dose
|
AUC0-t
Time Frame: predose to 216 hours post dose
|
90% CI of AUC0-t of non-liposome-encapsulated and total Amphotericin B
|
predose to 216 hours post dose
|
AUC0-∞
Time Frame: predose to 216 hours post dose
|
90% CI of AUC0-∞ of non-liposome-encapsulated and total Amphotericin B
|
predose to 216 hours post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: XiaoAi He, Haikou People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 2, 2023
Primary Completion (Actual)
September 1, 2023
Study Completion (Actual)
September 1, 2023
Study Registration Dates
First Submitted
May 31, 2023
First Submitted That Met QC Criteria
June 12, 2023
First Posted (Actual)
June 22, 2023
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 27, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HC1507-004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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