A Pilot Bioequivalence Study Between Amphotericin B Liposome for Injection and AmBisome® in Healthy Subjects

NCT ID: NCT04993222

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-04
• Study Completion Date: 2020-11-16

Brief Summary

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.

Conditions

Bioequivalence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Amphotericin B liposome for injection

Intervention Type: DRUG

IV infusion

AmBisome®

Intervention Type: DRUG

IV infusion

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.

Group Type: EXPERIMENTAL

Amphotericin B liposome for injection

Intervention Type: DRUG

IV infusion

AmBisome®

Intervention Type: DRUG

IV infusion

Interventions

Amphotericin B liposome for injection

IV infusion

Intervention Type: DRUG

AmBisome®

IV infusion

Intervention Type: DRUG

Other Intervention Names

the test product; the reference product

Eligibility Criteria

Inclusion Criteria

1. Subjects fully understand and voluntarily participate in this study and sign informed consent.

2. Healthy female and male volunteers aged 18-55 years.

3. 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).

4. Subjects must be in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.

5. Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion Criteria

1. History of allergic reactions to amphotericin B or its analogs. History of allergy to two or more kinds of drugs or food.

2. 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.

3. Use of any prescription or over the counter medication within 14 days prior to screening.

4. History of drug abuse within 6 months prior to screening.

5. 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.

6. Consumption of alcohol in excess of 14 units/week within 3 months prior to screening.

7. Consumption excessive amounts of tea, coffee and/or caffeine-rich beverages daily within 3 months prior to screening.

8. Participation in other trial within 3 months prior to screening.

9. Donation or loss of more than 400 mL blood within 3 months prior to screening.

10. Subject (female) is lactating or pregnant.

11. Subject who cannot tolerate venipuncture or have a history of needle and blood sickness.

12. Subject who has special requirements on diet and cannot accept the uniform diet.

13. 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.

14. Any positive test result for Hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti-syphilis spirochete.

15. Female subjects with positive pregnancy test results during the screening period or during the study.

16. Positive test result for alcohol screening or drug abuse.

17. 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.

18. Not suitable for this study as determined by the investigator due to other reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wuhan Medical Treatment Center

Wuhan, Hubei, China

Countries

China

Other Identifiers

HC1507YBE201901

Identifier Type: -

Identifier Source: org_study_id