- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04993222
A Pilot Bioequivalence Study Between Amphotericin B Liposome for Injection and AmBisome® in Healthy Subjects
July 28, 2021 updated by: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
A Randomized, Open-label, Two-preparation, Single-dose, Two-sequence Pilot Bioequivalence Study Between Amphotericin B Liposome for Injection and AmBisome® in Healthy Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
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
-
-
Hubei
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Wuhan, Hubei, China, 430040
- Wuhan Medical Treatment Center
-
-
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
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
IV infusion
Other Names:
IV infusion
Other Names:
|
EXPERIMENTAL: 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.
|
IV infusion
Other Names:
IV infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bioequivalence based on Cmax
Time Frame: 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%.
|
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
|
Bioequivalence based on AUC0-t
Time Frame: 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%.
|
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
|
Bioequivalence based on AUCinf
Time Frame: 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%.
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tmax of liposome-encapsulated and non-liposome-encapsulated Amphotericin B
Time Frame: 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
|
Time of maximum observed concentration
|
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
Time Frame: 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
|
Terminal elimination half-life
|
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
Time Frame: 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
|
Apparent elimination rate constant
|
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
Time Frame: 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
|
Extrapolated area
|
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
Time Frame: 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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 4, 2020
Primary Completion (ACTUAL)
September 8, 2020
Study Completion (ACTUAL)
November 16, 2020
Study Registration Dates
First Submitted
July 7, 2021
First Submitted That Met QC Criteria
July 28, 2021
First Posted (ACTUAL)
August 6, 2021
Study Record Updates
Last Update Posted (ACTUAL)
August 6, 2021
Last Update Submitted That Met QC Criteria
July 28, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HC1507YBE201901
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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