EUCTR2016-003139-39-ES进行中（未招募）1 期
Double-blind, randomized, placebo-controlled, Single-center, Exploratory Clinical Trial to Investigate Safety and Efficacy of COMBOPROFEN for treatment of muscular pain associated with DOMS
Spherium Biomed0 个研究点开始时间: 2017年3月10日最近更新:
试验速览
- 阶段
- 1 期
- 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.Healthy male subjects, 18-45 years (inclusive) of age at the time of enrolment.
- •2.Body weight within normal range (Quetelet’s index between 19 and 30) expressed as weight (kg) / height (m2).
- •3.Normal clinical records and physical examination.
- •4.No known musculoskeletal pathology.
- •5.Laboratory tests (hematology and biochemistry) within the range of normal values, according to the Biochemistry laboratory reference values of the ‘Hospital de la Santa Creu i Sant Pau’. Variations may be admitted according to the clinical criteria of the CIM-Sant Pau.
- •6.Clinically acceptable temperature, blood pressure and pulse rate in supine and standing position (SBP between 100-140 mm Hg/ DBP between 50-90 mm Hg / HR between 50-100 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
- •7.To be able to understand the nature of the study and comply with all their requirements.
- •8.Free acceptance to participate in the study by obtaining signed informed consent form approved by the CREC.
- •9.Not engaged in regular lower extremity fitness activities for more than 2 times per week for = 2 consecutive weeks in the past 6 months before screening.
- •10.Report 24 or 48 hours post exercise, a pain intensity score = 4 in a 11 point-NRS scale while walking.
- •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 70
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.History of alcohol dependence or drug abuse in the last 1 year or daily consumption of alcohol > 40 g/day for men or 24 g/day for women.
- •2.Heavy consumer of stimulating beverages (>5 coffees, teas, chocolate or cola drinks per day) and grapefruit juice.
- •3.Background of allergy, idiosyncrasy or hypersensitivity to drugs.
- •4.Intake of any medication within 4 days prior to induction of DOMS that could interfere with pain or muscle function, including over-the-counter products (including natural food supplements, vitamins and medicinal plants products), any source of magnesium and vitamin c and ionic and protein supplements.
- •5.Positive serology for hepatitis B, C or HIV.
- •6.Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological or neurological disease or other chronic diseases.
- •7.12 lead ECG obtained at screening with PR = 220 msec, QRS =120 msec and QTc = 440 msec, bradycardia (<50 bpm) or clinically significant minor ST wave changes or any other abnormal changes on the screening ECG that would interfere with measurement of the QT interval.
- •8.Having undergone major surgery during the previous 6 months.
- •9.Smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc.) from 6 months prior to drug administration.
- •10.Participation in another clinical trial during the 3 months preceding the drug administration.
- •11.Donation of blood during the 4 weeks preceding the drug administration.
- •12.Acute illness four weeks before drug administration.
- •13.Clinically significant abnormal laboratory values (as determined by the PI) at the screening evaluation.
- •14.Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract
- •15.Positive results of the drugs at screening period, the day before starting induction of DOMS or before starting treatment. A minimum list of 6 drugs will be screened for inclusion: Amphetamines, Cocaine, Ethanol, Opiates, Cannabinoids and Benzodiazepines (positive results may be repeated at the discretion of the PI).
- •16.Subjects who have been engaged in regular lower extremity fitness activities within 4 days prior to visit 2 (induction of DOMS)
研究者
相似试验
已完成
不适用
Double-blind, placebo-controlled, randomized, single-ascending dose study to investigate the tolerability, safety, pharmacokinetics, pharmacodynamics, absolute bioavailability, mass balance, and metabolism of ACT-541468 in healthy male subjectsSleep disordersSleeping disordersinsomniaNL-OMON41910Actelion Pharmaceuticals56
进行中（未招募）
1 期
Influenza virus challenge study to test monocloncal antibody CT-P27 as a treatment for influenza (flu)MedDRA version: 16.1Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestationsInfluenzaEUCTR2013-004544-32-GBCelltrion, Inc
已完成
不适用
Randomised, double-blind, placebo-controlled, single-dose, dose-escalation study of the safety, tolerability, and pharmacokinetics of Lu AA24493 in acute ischemic strokeischemic stroke10007963NL-OMON31272undbeck5
尚未招募
2 期
Safety, tolerability and pharmacokinetics of SSTK-101 in healthy volunteersACTRN12624001064594SKYDD Biotechnology Pty Ltd38
已完成
1 期
Safety, tolerability, PK and PD of SCO-094 in type 2 diabetic patientsType 2 diabetesJPRN-jRCT1080225227SCOHIA PHARMA, Inc.68