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

Haisco Pharmaceutical Group

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

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

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT07057609

HSK-54-BE-2018

Details and patient eligibility

About

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

Enrollment

36 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy Chinese male or female participants aged 18-55 years (inclusive).
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).
No potential difficult airway or loose teeth.
No history of anesthesia-related complications or adverse events.
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.
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.
Capable of comprehending study procedures, willing to provide written informed consent, and able to comply with the trial protocol.

Exclusion criteria

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.
Severe infection, trauma, or major surgery within 4 weeks prior to screening, or planned surgical procedures during the study period.
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.
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).
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.
Smoking >5 cigarettes/day within 3 months prior to screening or inability to abstain from smoking during the study.
Use of prescription drugs, over-the-counter (OTC) medications, supplements (including vitamins), or herbal remedies within 2 weeks prior to screening.
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.
History or current diagnosis of autonomic dysfunction (e.g., recurrent syncope, palpitations) within the past 3 years.
Severe sleep apnea syndrome.
Positive serological tests for HBsAg, HCV antibodies, Treponema pallidum antibodies, or HIV antibodies.
Family history of malignant hyperthermia.
Hemophobia, needle phobia, or inability to tolerate venipuncture.
Lactating females or positive pregnancy test during screening or the study period.
Dietary restrictions incompatible with study center meals or protocol requirements.
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.
Any other condition deemed by the investigator to compromise subject safety or data validity.