NL-OMON51001已完成不适用
Single-centre, randomised, prospective, open-label, three-period, Phase 1 clinical trial for assessment of the pharmacodynamic and pharmacokinetic interaction of remimazolam and remifentanil - Remix2 study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Healthy male or female adults *18 to *70 years old
- •* American Society of Anesthesiologists (ASA) Physical Status 1
- •* Body mass index (BMI) >18 or <30 kg/m2
- •* Bilateral patent a. radialis
- •* For female volunteers of childbearing potential: Negative results of 2
- •pregnancy tests, the first test taken at the start of Screening and the second
- •test taken from the morning urine within 3 hours before the start of the
- •administration of the IMP as well as consent to use highly effective birth
- •control from the last menstrual cycle prior to the start of the IMP until the
- •end of the trial follow-up procedures. For definition of childbearing potential
- •and highly effective birth control, see protocol.
- •* For male participants, their partner must not become pregnant during the
- •trial. They should inform their partner about this.
- •* Subject agrees not to use alcohol for 2 days, not to use nicotine for 1 week,
- •and not to use recreational drugs for 2 weeks prior to the first period until
- •End of Trial
- •* Understanding of the trial procedures and be willing to follow the
- •instructions of the Investigator or centre staff during the course of the
- •clinical trial
- •* Written informed consent obtained from the subject
排除标准
- •* Known intolerance to benzodiazepines, flumazenil, opioids or any ingredients
- •of the remimazolam drug products (e.g., dextran, lactose)
- •* Pregnancy, or currently breastfeeding
- •* Have current neurological disorder(s) (epilepsy, the presence of a brain
- •tumour, a history of brain surgery, hydrocephalic disorders, depression needing
- •treatment with anti-depressive drugs, a history of brain trauma, a
- •subarachnoidal bleeding, TIA or cerebral infarct, psychosis or dementia,
- •schizophrenia, alcohol or drug abuse).
- •* Have a disease(s) involving the cardiovascular system (hypertension, coronary
- •artery disease, prior acute myocardial infarction, any valvular and/or
- •myocardial disease involving decrease in ejection fraction, arrhythmias, which
- •are either symptomatic or require continuous medication/pacemaker/automatic
- •internal cardioverter defibrillator)
- •* Recent (<3 months) use of psycho-active medication (benzodiazepines,
- •anti-epileptic drugs, Parkinson*s medication, neuroleptics, anxiolytics,
- •anti-depressant drugs, opioid analgesics)
- •* A history of illicit drug or alcohol abuse within two years prior to screening
- •* Any ongoing condition considered by the Investigator as potentially relevant
- •to the trial
- •* Any medical history considered by the Investigator as potentially relevant to
- •* An employee or direct relative of an employee of the trial site, the CRO or
- •the Sponsor.
- •* Resting HR <45 bpm or *90 bpm OR resting SABP <90 mmHg or *140 mmHg OR
- •resting DABP <50 mmHg or *90 mmHg, except for those cases of mild hypertension
- •or tachycardia which is considered to be secondary to anxiety or known white
- •coat hypertension.
- •* Positive urine drug screening test (amphetamines, methamphetamines,
- •benzodiazepines, barbiturates, marijuana, cocaïne, and opioids).
- •* Positive Covid-19 screening test
- •* Any participant as judged by the PI or Sub-Investigator to be inappropriate
- •for the trial for any other reason
- •* Clinically significant, as judged by the Investigator abnormal ECG
- •* Clinically significant abnormal laboratory values
- •* Participation in a clinical trial of an Investigational Drug or Medical
- •Device within three months prior to the Screening Visit
- •* Blood donation of *500mL within three months prior to Screening Visit
- •* Prior participation in this clinical trial. However, non-dosed drop-outs can
- •participate in the trial again but will need to be-rescreened.
研究者
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