NL-OMON41921已完成不适用
A single-centre randomized double-blind, double-dummy, placebo-controlled, four-way crossover study in healthy subjects to investigate the effect of ethanol 0.5 and 1.0 g/L and alprazolam 1 mg on a driving simulator and to compare the results with the NeuroCart test battery. - Driving simulator 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
- •Eligible subjects must meet all of the following inclusion criteria:
- •1. Healthy subjects, aged 18 to 55 years, inclusive; healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including 12-lead ECG, and clinical laboratory tests.
- •2. Subjects are in possession of a valid driver*s license and are active and experienced drivers; this is to be determined by the investigators;
- •3. Evidence of a personally signed and dated informed consent form indicating that the study subject has been informed of all pertinent aspects of the study.
- •4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.
- •5. Experienced alcoholic drinkers, with occasional well-tolerated self-exposure to eight alcohol-containing drinks per social occasion.
- •6. Female subjects of childbearing potential must have a negative (β-hCG) test (at screening and before the start of each occasion) and be willing and able to use one of the following double-barrier methods of birth control: hormonal intrauterine device with condom, or oral contraceptives with condom from the screening visit to the end of study
排除标准
- •Eligible subjects must meet none of the following exclusion criteria:
- •1. Confirmed or suspected myasthenia gravis, severe respiratory insufficiency, sleep apnoea syndrome, severe hepatic insufficiency or hypersensitivity to benzodiazepines;
- •2. Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •3. Any condition possibly affecting drug absorption (e.g., gastrectomy).
- •4. A positive urine drug screen for cocaine, amphetamine, morphine, benzodiazepine and THC.
- •5. Subject is not able to perform the drive simulator tests.
- •6. Treatment with an investigational drug within 3 months prior to screening or having participated in more than 4 investigational drug studies within 1 year prior to screening.
- •7. Use of (non-)prescription medications that are believed to affect subject safety or the overall results of the study following judgment by the investigator.
- •8. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
- •9. Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
- •10. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- •11. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects directly involved in the conduct of the study.
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