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BioequivalencePhase 1NCT05913921

Bioequivalence of Amphotericin B Liposome for Injection

A Phase 1 study testing Amphotericin B liposome for injection and AmBisome in people with Bioequivalence, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Bioequivalence
What is being tested?
Amphotericin B liposome for injection and AmBisome
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
2 Jun 2023to 1 Sep 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Haikou people's Hospital

    Haikou, Hainan

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Bioequivalence
Being tested
Amphotericin B liposome for injection, AmBisome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amphotericin B liposome for injectionDrug

    Also called the test product

    IV infusion, 2.0 mg/kg

  • AmBisomeDrug

    Also called the reference product

    IV infusion, 2.0 mg/kg

Study groups in NCT05913921
Study groupRoleWhat they receive
Sequence TRExperimental16 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
Receives: Drug: Amphotericin B liposome for injection; Drug: AmBisome
Sequence RTExperimental16 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
Receives: Drug: Amphotericin B liposome for injection; Drug: AmBisome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bioequivalence based on Cmax

    90% CI of Cmax of liposome-encapsulated Amphotericin B between Amphotericin B liposome for injection and AmBisome® within 80.00%~125.00%

    Measured: predose to 216 hours post dose

  2. Bioequivalence based on AUC0-t

    90% CI of AUC0-t of liposome-encapsulated Amphotericin B between Amphotericin B liposome for injection and AmBisome® within 80.00%~125.00%

    Measured: predose to 216 hours post dose

  3. Bioequivalence based on AUCinf

    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%

    Measured: predose to 216 hours post dose

Secondary outcomes (3)

  1. Cmax

    90% CI of Cmax of non-liposome-encapsulated and total Amphotericin B

    Measured: predose to 216 hours post dose

  2. AUC0-t

    90% CI of AUC0-t of non-liposome-encapsulated and total Amphotericin B

    Measured: predose to 216 hours post dose

  3. AUC0-∞

    90% CI of AUC0-∞ of non-liposome-encapsulated and total Amphotericin B

    Measured: predose to 216 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start2 Jun 2023
  3. Primary completion1 Sep 2023
  4. Study completion1 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05913921
Sponsor's protocol ID
HC1507-004
Status last verified
Sep 2023
First submitted
31 May 2023
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Amphotericin B liposome for injection and AmBisome in people with Bioequivalence, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bioequivalence based on Cmax (time frame: predose to 216 hours post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05913921.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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