NCT03758469已完成1 期
A Single-Center, Open-Label, Randomized, Two-Stage, Two-Way Crossover Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Rifampin Capsules in Healthy Subjects.
Sichuan Haisco Pharmaceutical Group Co., Ltd1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年12月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Peak concentration (Cmax)
研究概览
简要总结
This is a Phase I, single-center, open-label, randomized,two-way crossover, propofol-controlled, two-stage study evaluating the safety and pharmacokinetics/pharmacodynamics of IV maintenance dose and IV single loade dose plus maintenance dose of HSK3486 emulsion for injection in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females with full capacity for civil conduct, aged ≥18 and ≤45 years old. Both male and female subjects should be enrolled;
- •Male subjects weighing ≥50 kg, female subjects weighing ≥45 kg. All subjects should have a body mass index (BMI) of ≥19.0 and ≤26.0 kg/m2;
- •Blood pressure between 100-139/60-89 mmHg; heart rate between 60-99 beats/min; body temperature between 35.8-37.5 °C; respiratory rate between 12-20 breaths/min; SpO2 when inhaling ≥95%;
- •Normal physical examinations, laboratory examinations (blood routine, blood biochemistry and urine routine), and 12-lead electrocardiogram (ECG), or abnormal but without clinical significance as judged by the investigators; no significantly potential difficult airway (modified Mallampati score I-II);
- •No previous history of major organ primary diseases, such as liver, kidneys, digestive tract, blood, and metabolic diseases; no history of malignant hyperthermia and other genetic conditions; no history of mental/neurological diseases; no history of epilepsy; no contraindications for deep sedation/general anesthesia; no clinically significant history of anesthesia accidents;
- •Subjects must understand the procedures and methods of this study, and be willing to provide informed consent and to complete the trial in strict accordance with trial protocol.
排除标准
- •Known sensitivity to excipients in HSK3486 injectable emulsion (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate and sodium hydroxide), rifampin, or contraindications mentioned in the prescribing information of rifampin; history of drug allergies (including anesthetics), allergic diseases, or those with hyperactive immune response;
- •In receipt of any one of the following medications or treatments during screening/baseline:
- •History of drug abuse or any signs of chronic benzodiazepines use (such as insomnia, anxiety, spasms) within 3 months prior to screening, or a positive urine drug test during baseline;
- •Participated in clinical trials involving any medications or medical devices within 3 months prior to screening, or subjects who have participated in 3 or more drug clinical trials within the past year;
- •In receipt of rifampin within 4 weeks prior to screening;
- •Serious infection, trauma or major surgery within 4 weeks prior to screening; or acute disease with clinical significance (determined by the investigator) within 2 weeks prior to screening, including GI diseases or infections (such as respiratory or CNS infections);
- •In receipt of propofol, other sedatives/anesthetics and/or opioid analgesics or compounds containing analgesics within 1 week prior to baseline;
- •In receipt of prescription drugs, Chinese herbal medicines, over-the-counter drugs or food supplements (such as vitamins and calcium supplements) other than contraceptives, paracetamol, oral non-steroidal anti-inflammatory drugs, topical over-the-counter preparations, within 2 weeks prior to baseline; unless the principal investigator (PI) and the sponsor agree that the medication has no effect on the safety and PK/PD results of the trial;
- •A history or evidence of any one of the following diseases prior to screening/baseline:
- •History of cardiovascular diseases such as: postural hypotension, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction within 6 months before screening, tachycardia/bradycardia requiring medication, third-degree atrioventricular block or QTcF interval ≥450 ms (Fridericia's correction formula);
- •Respiratory insufficiency, history of obstructive pulmonary disease, history of asthma, sleep apnea; history of failed tracheal intubation; history of bronchospasm requiring treatment within 3 months prior to screening; acute respiratory infection, and with obvious symptoms such as fever, wheezing, nasal congestion or cough within 1 week prior to baseline;
- •History of GI tract diseases: Gastrointestinal obstruction, active GI bleed, potential for reflux and aspiration;
- •Laboratory results that meet any of the following during screening/baseline:
- •Positive result for either HBsAg, HCV, HIV, or syphilis;
- •Abnormal hepatic or renal function confirmed after re-examination;
- •ALT or AST > 1×ULN;
- •Creatinine > 1×ULN;
- •TBIL > 1.0×ULN;
- •History of alcohol abuse within 3 months prior to screening, abuse defined as average of > 2 units of alcohol per day (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or positive result for breath alcohol test during baseline;
- •Smoke more than 5 cigarettes per day and a total of more than 60 cigarettes within 3 months prior to screening;
- •Blood donation or blood loss ≥200 mL within 30 days prior to screening; plasma donation or plasma exchange within 7 days prior to screening;
- •Subjects who consume any beverages or foods containing alcohol, grapefruit juice or methylxanthine (such as coffee, tea, coca-cola, chocolate, functional drinks), to participate in strenuous physical activities and other factors that may affect drug absorption, distribution, metabolism, and excretion within 2 days prior to enrollment; subjects who are unable to fast for 8 hours prior to dose administration;
- •Subjects expected to have surgery or hospitalization during the trial;
- •Subjects unsuitable for arterial blood collection, such as subjects who have positive Allen's test;
- •Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial; subjects who are planning pregnancy within 1 month after the completion of the trial (including male subjects);
- •Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.
研究组 & 干预措施
HSK3486
Experimental
0.4 mg/kg
干预措施: HSK3486 (Drug)
rifampin , HSK3486
Experimental
600 mg;0.4 mg/kg
干预措施: rifampin , HSK3486 (Drug)
结局指标
主要结局
Peak concentration (Cmax)
时间窗: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Area under the concentration-time curve (AUC0-t, AUC0-∞)
时间窗: From the start of HSK3486 administration to 24 h after the start of administration on day 1
次要结局
- MOAA/S(modified observer's assessment of alert /sedation)-time curve(From the start of HSK3486 administration until the subjects is fully awake on day 1)
- BIS(bispectral index)-time curve(From the start of HSK3486 administration to 60 min after the start of administration on day 1)
- Urine routine test(From the start of HSK3486 administration to 24 h after the start of administration on day 1)
- Blood biochemical examination(From the start of HSK3486 administration to 24 h after the start of administration on day 1)
- Number of patients with adverse events(From the start of HSK3486 administration to 24 h after the start of administration on day 1)
- Respiratory rate or blood oxygen saturation(From the start of HSK3486 administration to 24 h after the start of administration on day 1)
- Terminal elimination half life (t1/2)(From the start of HSK3486 administration to 24 h after the start of administration on day 1)
- Time to fully awake(From the start of HSK3486 administration until the subjects is fully awake on day 1)
- Blood pressure(From the start of HSK3486 administration to 24 h after the start of administration on day 1)
- Heart rate(From the start of HSK3486 administration to 24 h after the start of administration on day 1)
- Blood routine test(From the start of HSK3486 administration to 24 h after the start of administration on day 1)
- 12-Electrocardiogram(From the start of HSK3486 administration to 24 h after the start of administration on day 1)
- Concurrent medications(From the start of HSK3486 administration to 24 h after the start of administration on day 1)
研究者
研究点 (1)
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