The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioequivalence of Amphotericin B Liposome for Injection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05913921
Recruitment Status : Completed
First Posted : June 22, 2023
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Bioequivalence Drug: Amphotericin B liposome for injection Drug: AmBisome Phase 1

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 2, 2023
Actual Primary Completion Date : September 1, 2023
Actual Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
 Drug: Amphotericin B liposome for injection
IV infusion, 2.0 mg/kg
Other Name: the test product

Drug: AmBisome
IV infusion, 2.0 mg/kg
Other Name: the reference product
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
 Drug: Amphotericin B liposome for injection
IV infusion, 2.0 mg/kg
Other Name: the test product

Drug: AmBisome
IV infusion, 2.0 mg/kg
Other Name: the reference product


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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%

  2. 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%

  3. 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 Outcome Measures :
  1. Cmax [ Time Frame: predose to 216 hours post dose ]
    90% CI of Cmax of non-liposome-encapsulated and total Amphotericin B

  2. AUC0-t [ Time Frame: predose to 216 hours post dose ]
    90% CI of AUC0-t of non-liposome-encapsulated and total Amphotericin B

  3. AUC0-∞ [ Time Frame: predose to 216 hours post dose ]
    90% CI of AUC0-∞ of non-liposome-encapsulated and total Amphotericin B


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects must give informed consent before the trial, fully understand the content, process and possible adverse reactions, and voluntarily sign a written informed consent.
  2. The subjects can communicate well with the investigators and complete the trial according to protocol.
  3. Sex: male or female subjects.
  4. Age of 18 - 55 years (inclusive).
  5. 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:

  1. Allergic constitution, or known history of allergy to the components of the study drug or similar drugs.
  2. 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).
  3. Subjects with liver and kidney diseases that affect the pharmacokinetic of drugs.
  4. Those who underwent major surgery within 6 months prior to initial administration, or who planned to undergo surgery during the study.
  5. 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).
  6. 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.
  7. 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.
  8. Use of any drug within 14 days prior to initial administration (except for topical drugs with local effects).
  9. Use of any investigational medicinal product within 3 months prior to initial administration.
  10. 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.
  11. Positive urine drug screening.
  12. 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.
  13. 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.
  14. 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.
  15. 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.

  16. 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:

  17. Pregnant or lactating women or those with positive pregnancy results.
  18. Those who have used oral contraceptives within 30 days prior to initial administration.
  19. Use of long-acting estrogen and/or progesterone injections and/or implants within 6 months prior to initial administration.
  20. Women of childbearing age who have unprotected sex with their partner within 14 days prior to initial administration.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05913921


Locations
Layout table for location information
China, Hainan
Haikou people's Hospital
Haikou, Hainan, China
Sponsors and Collaborators
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: XiaoAi He Haikou People's Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
ClinicalTrials.gov Identifier: NCT05913921    
Other Study ID Numbers: HC1507-004
First Posted: June 22, 2023    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
 Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents