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 range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.