EUCTR2007-001688-31-FR进行中（未招募）不适用
Monitoring des états cognitifs chez des sujets volontaires sains, sur 2 périodes, l'une avant et après administration d'une dose unique de Zolpidem, l'autre sans administration de traitement
arime company of the Mediscis group0 个研究点开始时间: 2007年4月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Male subjects aged 18 to 50 years. The subjects included in the princeps study (protocol referenced 604296) are requested to take part in the present study and are firstly acceptable
- •2. Right-handed-person
- •3. Having a normal vision or corrected by contact lenses
- •4. Not having any known auditive deficit
- •5. Absence of dyslexia
- •6. Absence of disorders of the training in childhood having required the consulting of a speech therapist
- •7. Understanding the study and agreeing to sign the inform consent form
- •8. Communicating easily with the investigator or his representatives
- •9. Having faculty and agreeing to adhere to the trial constraints
- •10. Non smoker
- •11. Healthy subjects according to the medical history, the physical examination, the vital signs and the electrocardiogram at selection visit
- •12. Body Mass Index between 18 and 28 and body weight between 50 and 90 kg
- •13. Having a blood pressure and a heart rate, measured in the standard conditions at the selection visit, after at least 10 minutes in the supine position, within the following limits : systolic pressure between 90 and 140 mmHg, diastolic pressure between 50 and 90 mmHg and heart rate between 40 and 90 bpm. After 2 minutes in standing position, there should be no SBP reduction greater than 20 mmHg or DBP reduction greater than 10 mmHg associated to clinical signs
- •14. Having a normal ECG at the selection visit after at least 10 minutes in the supine position : PR between 120 and 210 ms, QRS = 120 ms and QTc (Bazett) = 440 ms. The Incomplete Right Bundle Branch Block will be accepted.
- •15. Subjects registered in French Health Ministry computerized file and authorized to participate in a clinical trial.
- •16. Affiliated with, or a beneficiary of, a French social security system in agreement with the French law on biomedical research (loi Huriet n° 88.1138 and its amendments)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any significant medical history or ongoing pathology being relevant (cardio-vascular, neurologic including epilepsy, hematological, hepatic, gastro-intestinal, renal, pulmonary, endocrinological, metabolic, psychiatric, cranial traumatism with loss of consciousness)
- •2. Colour-blind subjects
- •3. Subjects carrying implant or metal objects (including glasses) likely to disturb the recording system
- •4. Subjects having disorders of comprehension and\or reading like dyslexia, highlighted by a reading test on computer screen
- •5. Subjects having night-respiratory disorders (sleep apnea syndrom) highlighted by a polysomnographic recording prior to cognitive tests
- •6. Significant pathology during the last 2 weeks before the inclusion visit
- •7. Taken any type of drugs during the last 14 days preceding the first evaluation or in an interval lower or equal to 6 times drug half life
- •8. History of chronic alcohol consumption (> 50g per day) and/or drug abuse
- •9. Excessive consumption of drink containing xanthic bases (coffee, tea, cola : greater than 4 cups or glasses per day)
- •10. A positive urine drug screen at the selection visit and at Day -1 (opiates, cannabinoïds, cocaine, benzodiazepines, amphetamines, barbiturates)
- •11. Positive reaction to any of the following tests: HBs antigen, anti-HCV antibodies, anti-HIV antibodies
- •12. Frequent episodes of migraine or headaches (=once per week)
- •13. An inversed nycthemeral life rythm or a change of life condition during the last 48 hours preceding the first evaluation (sleepless night, night-work)
- •14. Subjects in the inability to sign an inform consent following linguistic or psychic problems
- •15. Subject who, in the judgment of the Investigator, is likely to be noncompliant or uncooperative during the study
- •16. Inability to be included after checking of the National File of Volunteers (according to indemnities limited to 4500 € within 12 months and exclusion period from a previous participation to a trial).
- •17. In custody due to administrative or legal decision or under tutelage or being admitted in a sanitary or social institution.
- •18. Subject who cannot be contacted in case of emergency
- •19. Presence or hisory of a clinically significant medicamentous allergy
- •20. Zolpidem contra-indications
- •- Myasthenia
- •- Hypersensitivity in zolpidem or in one of its constituents (lactose notably)
- •- Obstructive sleep apnea
研究者
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