NL-OMON42052已完成不适用
A randomized, double-blind, double-dummy, placebo-controlled, single dose, 4-way cross-over study of the reversibility of cognitive deficits induced by a nicotinic anti-cholinergic challenge with mecamylamine by a cholinesterase inhibitor and a nicotinic receptor agonist - Validation of the mecamylamine model
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
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.Healthy male subjects, 18 to 45 years of age, inclusive. Healthy status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, and urinalysis;;2.Body Mass Index (BMI) between 18 kg/m2 and 32 kg/m2;;3.Incidental smokers (defined as smoking tobacco at least once a month and no more than 5 cigarettes per day);;4.Able to participate and willing to provide written informed consent and to comply with the study restrictions.
排除标准
- •1.Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history taking and physical examinations obtained during the screening visit as judged by the investigator;;2.Any disease associated with cognitive impairment, including schizophrenia and dementia;;3.Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), electrocardiogram (ECG) and vital signs, or physical findings at screening (as judged by the investigator);;4.Presence of orthostatic hypotension as defined by a decrease of blood pressure >= 20 mmHg systolic or >= 10 mmHg diastolic, measured 2 min after standing up; ;5.Evidence of elevated blood pressure at screening of >140 mmHg systolic or >90 mmHg diastolic;;6.Positive Hepatitis B surface antigen (HBsAG), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening;;7.History of alcoholism or substance abuse within three years prior to screening;;8.Subject is unable to refrain from alcohol consumption during study confinement and at least 24 hours before screening, before dosing, and before each scheduled visit;;9.Subject is a habitual and heavy consumer of caffeinated beverages (more than 8 cups of coffee or equivalent/day) and/or is not able to refrain from use of (methyl) xanthines (e.g. coffee, tea, cola, chocolate) from 24 hours prior to dosing until discharge from the CRU for each study period;;10.Positive urine drug screen (UDS) or alcohol test at screening and/or Day 1 of each period;;11.Subject is unable to refrain from the use of concomitant medication which, in the opinion of the investigator, interferes with their ability to participate in the study, from 7 days prior to dosing on Day 1 Period 1 until end of study;;12.Subject has a history of severe allergies, or has had an anaphylactic reaction to prescription or non-prescription drugs or food;;13.Known hypersensitivity to the investigational drug or comparative drug or drugs of the same class, or any of their excipients. ;14.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;;15.Currently using any nicotine replacement therapy, smoking cessation medications or remedies, including varenicline (Chantix ®) or have used any nicotinic products for smoking cessation within 3 months of screening; ;16.History of allergic reaction to nicotine-containing products ;17.Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug (Day 1 Period 1) or more than 4 times per year;;18.Donation or loss of more than 500 mL blood within three months prior to screening;;19.Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject.
研究者
相似试验
招募中
4 期
A clinical trial to understand changes in exhaled breath and lung function tests with different doses of inhaled steroid (Beclomethasone dipropionate) in moderate to severe asthma patients.CTRI/2018/02/011953Chest Research Foundation
已完成
3 期
Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease(COPD) ICTRI/2009/091/000141Boehringer Ingelheim Shanghai Pharmaceuticals Co Ltd860
已完成
不适用
A randomized, double-blind, double-dummy, placebo-controlled, 3-way crossover proof of concept study of intradermally administered desmopressin in healthy volunteers using a nanoporous microneedle array.NL-OMON48081MyLife Technologies6
进行中（未招募）
1 期
A study to evaluate the effects of indacaterol maleate as a new formulation in the EPIC test fixture.Persistent AsthmaMedDRA version: 14.1Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2011-001824-39-GBovartis Pharma Services AG
已完成
3 期
Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease(COPD) IICTRI/2009/091/000147Boehringer Ingelheim Pharmaceuticals860