EUCTR2006-005140-89-NL进行中（未招募）1 期
A PHASE I, DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED (WITHIN EACH GROUP) STUDY TO EVALUATE THE INTERACTION BETWEEN ORALLY ADMINISTERED TYRAMINE HYDROCHLORIDE AND RASAGILINE MESILATE IN HEALTHY SUBJECTS - Tyramine challenge study
TEVA Pharmaceuticals Industries Ltd0 个研究点目标入组 160 人开始时间: 2006年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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
- All
入选标准
- •1.Gender: male or female;
- •2.Age: between 40 and 70 years of age, inclusive;
- •3.BMI:19.0 – 30.0 kg/m2 [Body Mass Index (BMI) (kg/m2) = Body weight (kg) ? Height2 (m2)];
- •4.Willingness to sign the written Informed Consent Form (ICF);
- •5.Willing to inpatient stay for the full length required by the protocol.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Clinically significant illnessess, as judged by the Medical Investigator, within 8 weeks prior to the first administration of tyramine.
- •2.Clinically significant surgery, as judged by the Medical Investigator, within 8 weeks prior to the first administration of tyramine.
- •3.Any clinically significant abnormality found during medical screening.
- •4.Any reason which, in the opinion of the Medical Investigator, would preclude safe and complete study participation.
- •5.Abnormal laboratory tests judged clinically significant.
- •6.Positive testing for hepatitis B, hepatitis C, or HIV at screening.
- •7.The mean of 3 consecutive supine systolic and diastolic BP readings taken within 10 minutes exceeds 140 mm Hg and 90 mmHg, respectively, and/or is not stable (supine SBP exceeds a maximum range of 10 mmHg between the lowest and highest values)
- •8.Clinically significant ECG, vital signs abnormalities or cardiovascular symptomatology observed during the bicycle exercise test at screening, as judged by the Medical Investigator, or positive suggestion of any cardiovascular symptomatology underline disease.
- •9.History of significant alcohol abuse or drug abuse within 1 year prior to the screening visit.
- •10.Regular use of alcohol within 6 months prior to the screening visit
- •11.Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs within 1 year prior to the screening visit or positive urine drug or alcohol screen at screening.
- •12.History of allergic reactions to rasagiline, phenelzine, tyramine or other related drugs.
- •13.Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first administration of tyramine.
- •14.Use of an investigational drug with unknown mechanism of action/unknown half-life or participation in an investigational first-in-man study within 90 days prior to the first administration of tyramine, or participation in any other investigational study within 60 days or 5 half-lives of the investigational study drug, which ever is longer, prior to the first administration of tyramine.
- •15.Clinically significant history or presence of any clinically significant gastrointestinal pathology, unresolved gastrointestinal symptoms, kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
- •16.Any clinically significant history or presence of clinically significant neurological, endocrinal, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
- •17.Use of prescription medication within 14 days prior to the first administration of tyramine or over-the-counter products within 7 days prior to the first administration of tyramine, especially sympathomimetics and except for topical products without systemic absorption or hormonal contraceptives.
- •18.Use of grapefruit products within 7 days prior to Period 1.
- •19.Difficulty to swallow study medication.
- •20.Any food allergy, intolerance, restriction or special diet that, in the opinion of the Medical Investigator, could contraindicate the subject‘s participation in this study.
- •21.A depot injection or an implant of any drug (other than hormonal contraceptive) within 3 months prior to the first administration of tyramine.
- •22.Donation of more than 50 mL blood within 3 months prior to the first administration of tyramine.
- •23.History or known presence of intracranial or systemic aneurysm, intracranial hemorrhage or pheochromocytoma.
- •24.Known adverse r
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