Bioequivalence Study of Propofol Medium and Long Chain Fat Emulsion Injection in Healthy Chinese Subjects

NCT ID: NCT07057609

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2019-03-22

Brief Summary

This study assessed the bioequivalence and safety of a single dose of Propofol Medium/Long Chain Fat Emulsion Injection (Test product, Haisco Pharmaceutical Group Co., Ltd.) compared to the reference product (Propofol Medium/Long Chain Fat Emulsion Injection, Fresenius Kabi Deutschland GmbH) in healthy Chinese subjects. Additionally, the pharmacodynamic profiles of both formulations were evaluated

Conditions

Healthy

Study Design

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

Study Groups

Test formulation

Propofol Medium and Long Chain Fat Emulsion Injection (20 mL:0.2g) Manufacturer: Haisco Pharmaceutical Group Co., Ltd

Group Type: EXPERIMENTAL

Tested Propofol Medium and Long Chain Fat Emulsion Injection (T)

Intervention Type: DRUG

Single-dose intravenous infusion of the test formulation under fasting conditions at 30 μg/kg/min. Infusion time: 30 minutes. Dosage: 900 μg/kg for both administrations

Reference formulation

Propofol Medium and Long Chain Fat Emulsion Injection (20 mL:0.2g) Manufacturer: Fresenius Kabi Deutschland GmbH

Group Type: EXPERIMENTAL

Reference Propofol Medium and Long Chain Fat Emulsion Injection (R)

Intervention Type: DRUG

Single-dose intravenous infusion of the reference formulation under fasting conditions at 30 μg/kg/min. Infusion time: 30 minutes. Dosage: 900 μg/kg for both administrations

Interventions

Tested Propofol Medium and Long Chain Fat Emulsion Injection (T)

Single-dose intravenous infusion of the test formulation under fasting conditions at 30 μg/kg/min. Infusion time: 30 minutes. Dosage: 900 μg/kg for both administrations

Intervention Type: DRUG

Reference Propofol Medium and Long Chain Fat Emulsion Injection (R)

Single-dose intravenous infusion of the reference formulation under fasting conditions at 30 μg/kg/min. Infusion time: 30 minutes. Dosage: 900 μg/kg for both administrations

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy Chinese male or female participants aged 18-55 years (inclusive).

2. Body weight ≥50.0 kg (male) or ≥45.0 kg (female), with a body mass index (BMI) of 19.0-26.0 kg/m² (inclusive).

3. No potential difficult airway or loose teeth.

4. No history of anesthesia-related complications or adverse events.

5. Normal or clinically nonsignificant findings in: physical examination, vital signs, laboratory tests (including complete blood count, urinalysis, blood biochemistry, coagulation profile, and pregnancy test for all females), 12-lead electrocardiogram (ECG), eligibility confirmed by the investigator despite minor abnormalities.

6. Participants (and their partners) agree to use effective contraception and avoid pregnancy plans from signing the informed consent form until 3 months after the last dose of the investigational product.

7. Capable of comprehending study procedures, willing to provide written informed consent, and able to comply with the trial protocol.

Exclusion Criteria

1. History or presence of clinically significant diseases affecting major systems (e.g., digestive, respiratory, urinary, cardiovascular, endocrine, neurological, hematological, immunological, psychiatric, or metabolic disorders), familial genetic disorders, or any condition deemed by the investigator to interfere with study outcomes.

2. Severe infection, trauma, or major surgery within 4 weeks prior to screening, or planned surgical procedures during the study period.

3. History of drug abuse (e.g., chronic use of NSAIDs, opioids, sedatives, or addictive substances) within 12 months prior to screening, or positive urine drug screen.

4. Hypersensitivity (e.g., drug/food allergies) or known allergy to propofol or excipients in propofol medium/long-chain triglyceride emulsion (e.g., soybean oil, medium-chain triglycerides, egg lecithin, glycerol, oleic acid, sodium hydroxide).

5. Excessive alcohol consumption (defined as >14 units/week; 1 unit = 360 mL beer, 45 mL 40% spirits, or 150 mL wine) within 6 months prior to screening, positive alcohol test, or unwillingness to abstain from alcohol during the study.

6. Smoking >5 cigarettes/day within 3 months prior to screening or inability to abstain from smoking during the study.

7. Use of prescription drugs, over-the-counter (OTC) medications, supplements (including vitamins), or herbal remedies within 2 weeks prior to screening.

8. Participation in another clinical trial within 3 months prior to screening, ongoing follow-up in another study, or planned enrollment in other trials during this study.

9. History or current diagnosis of autonomic dysfunction (e.g., recurrent syncope, palpitations) within the past 3 years.

10. Severe sleep apnea syndrome.

11. Positive serological tests for HBsAg, HCV antibodies, Treponema pallidum antibodies, or HIV antibodies.

12. Family history of malignant hyperthermia.

13. Hemophobia, needle phobia, or inability to tolerate venipuncture.

14. Lactating females or positive pregnancy test during screening or the study period.

15. Dietary restrictions incompatible with study center meals or protocol requirements.

16. Consumption of specific foods/beverages (e.g., grapefruit, xanthine-containing products) or substances affecting drug ADME (absorption, distribution, metabolism, excretion) within 48 hours prior to dosing.

17. Any other condition deemed by the investigator to compromise subject safety or data validity.

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

Sponsors

Haisco Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Countries

China

Other Identifiers

HSK-54-BE-2018

Identifier Type: -

Identifier Source: org_study_id