NL-OMON38728已完成不适用
Double blind, placebo controlled, randomized study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oxathridine after a single oral administration ranging from 0.5 mg to 100 mg in healthy male subjects (part 1) followed by the assessment of the effect of 3 different oxathridine oral doses on polysomnography in comparison to 50 mg diphenhydramine and placebo in healthy male subjects (part 2). - Safety, pharmacokinetics and pharmacodynamics of BP1.5375
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bioprojet
- 入组人数
- 74
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
- •1. Signed informed consent prior to any study-mandated procedure.
- •2. Healthy male subjects aged between 18 and 45 years (inclusive).
- •3. Subjects with a body weight of at least 50 kg and a body mass index (BMI) between 18.0 and 28.0 kg/m2 (both inclusive).
- •4. Healthy subjects, based on history, physical examination, complete laboratory evaluation, and 12-lead ECG.
- •5. Normal arterial blood pressure (BP) and pulse rate or, if abnormal, considered not clinically significant by the investigator. Normal BP to be [100-140] mmHg systolic and [45-90] mmHg diastolic. Normal pulse rate to be [40-90] bpm after 5 minutes rest in lying position.
- •6. Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.
排除标准
- •1.Subject with a history of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurological, psychiatric, systemic, or infectious disease, or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject, or impact the validity of the study results.
- •2. Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- •3. Haematology, clinical chemistry, and urinalysis results deviating from the normal range to a clinically relevant extent at screening.
- •4. Clinically significant findings on physical examination at screening.
- •5. 12-lead electrocardiogram (ECG) with clinically relevant abnormalities in supine position at screening.
- •6. Positive results from urine drug screen at screening.
- •7. Veins unsuitable for i.v. puncture on either arm (e.g., veins that are difficult to locate, access or puncture, or veins with a tendency for rupture during or after puncture).
- •8. Treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John*s Wort) within 2 weeks prior to the (first) scheduled administration of study drug, except paracetamol (maximum 1 g/day).
- •9. Treatment with another investigational drug within 3 months prior to screening or having participated in more than four investigational drug studies within 1 year prior to screening.
- •10. History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
- •11. History or clinical evidence of any disease, and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs.
- •12. Have undergone surgery or have donated an amount equal or more than 500 mL blood, or 300 mL of plasma, within 3 months prior to screening.
- •13. Positive results from any of the hepatitis serology tests (HBsAg, anti-HCV), at screening.
- •14. Positive results from the HIV 1 or/and 2 serology at screening.
- •15. History of allergy to diphenhydramine or antihistaminic drugs.
- •16. Smoking more than 5 cigarettes per day.
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