Bioequivalence and Safety Study of Propofol Medium and Long Chain Fat Emulsion Injection in Healthy Chinese Subjects : A Randomized, Open-label, Single-dose, Cross-over Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Test formulation
Propofol Medium and Long Chain Fat Emulsion Injection (20 mL:0.2g) Manufacturer: Haisco Pharmaceutical Group Co., Ltd
干预措施: Tested Propofol Medium and Long Chain Fat Emulsion Injection (T) (Drug)
Reference formulation
Propofol Medium and Long Chain Fat Emulsion Injection (20 mL:0.2g) Manufacturer: Fresenius Kabi Deutschland GmbH
干预措施: Reference Propofol Medium and Long Chain Fat Emulsion Injection (R) (Drug)
结局指标
主要结局
Cmax
时间窗: From the start of intravenous infusion to 480 minutes after the intravenous infusion
The maximum blood concentration, the pharmacokinetic parameters of Propofol in plasma
AUC(0-t)
时间窗: From the start of intravenous infusion to 480 minutes after the intravenous infusion
The area under the blood concentration-time curve from time 0 to the last accurately measurable concentration at sample collection time t was measured, the pharmacokinetic parameters of Propofol in plasma
AUC(0-∞)
时间窗: From the start of intravenous infusion to 480 minutes after the intravenous infusion
The area under the blood concentration-time curve from 0 to infinite time (∞), the pharmacokinetic parameters of Propofol in plasma
次要结局
- BIS AUC0-60min(From the start of intravenous infusion to 60 minutes after the intravenous infusion)
- BISmin(From the start of intravenous infusion to 60 minutes after the intravenous infusion)
- t-BISmin(From the start of intravenous infusion to 60 minutes after the intravenous infusion)
- AEs(From the time of signing ICF to the end of follow-up，up to 10 days)