Bioequivalence Study of Propofol Medium and Long Chain Fat Emulsion Injection in Healthy Chinese … (NCT07057609) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study of Propofol Medium and Long Chain Fat Emulsion Injection in Healthy Chinese Subjects
China36 participantsStarted 2018-10-16
Plain-language 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
Who can participate
Age range18 Years – 55 Years
SexALL
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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.
What they're measuring
1
Cmax
Timeframe: From the start of intravenous infusion to 480 minutes after the intravenous infusion
2
AUC(0-t)
Timeframe: From the start of intravenous infusion to 480 minutes after the intravenous infusion
3
AUC(0-∞)
Timeframe: From the start of intravenous infusion to 480 minutes after the intravenous infusion
. 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.