NL-OMON50771已完成不适用
A phase I, open label clinical trial in healthy volunteers, to assess and characterize the effect of FIRTECH infrared patch on tissue perfusion, oxygenation and local microcirculation. - FIRTECH local blood microcirculation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
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 64（—）
入选标准
- •1. Signed informed consent prior to any study-mandated procedure
- •2. Healthy male or female subjects, 18 to 55 years of age, inclusive.
- •3. Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and
- •with a minimum weight of 50 kg.
- •4. Has the ability to communicate well with the Investigator in the Dutch
- •language and willing to comply with the study restrictions.
排除标准
- •1. Evidence of any active or chronic disease or condition that could interfere
- •with, or for which the treatment of might interfere with, the conduct of the
- •study, or that would pose an unacceptable risk to the subject in the opinion of
- •the investigator (following a detailed medical history, physical examination,
- •vital signs (systolic and diastolic blood pressure, pulse rate, body
- •temperature) and12-lead electrocardiogram (ECG)). Minor deviations from the
- •normal range may be accepted, if judged by the Investigator to have no clinical
- •2. Clinically significant abnormalities, as judged by the investigator, in
- •laboratory test results (including hepatic and renal panels, complete blood
- •count, chemistry panel and urinalysis). In the case of uncertain or
- •questionable results, tests performed during screening may be repeated before
- •patch side location randomization to confirm eligibility or judged to be
- •clinically irrelevant for healthy subjects.
- •3. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and
- •diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg at
- •4. Use of any medications (prescription or over the counter [OTC]), within 14
- •days of study product administration, or less than 5 half-lives (whichever is
- •longer). Exceptions are paracetamol (up to 4 g/day) and ibuprofen (up to
- •1g/day). Other exceptions will only be made if the rationale is clearly
- •documented by the investigator.
- •5. Use of any vitamin, mineral, herbal, and dietary supplements within 7 days
- •of study product administration, or less than 5 half-lives (whichever is
- •longer). Exceptions will only be made if the rationale is clearly documented by
- •the investigator.
- •6. Participation in an investigational drug or device study (last dosing of
- •previous study was within 30 days prior to first dosing of this study).
- •7. History of abuse of addictive substances (alcohol, illegal substances) or
- •current use of more than 21 units alcohol per week, drug abuse, or regular user
- •of sedatives, hypnotics, tranquillizers, or any other addictive agent
- •8. Positive test for drugs of abuse at screening.
- •9. Alcohol will not be allowed from at least 24 hours before screening.
- •10. Active smoker (i.e. on average >3 cigarettes per day in the last 3 months)
- •11. Excess of caffeine consumption (more than eight cups of coffee or
- •equivalent per day)
- •12. Any confirmed significant allergic reactions (urticaria or anaphylaxis)
- •against any drug, or multiple drug allergies (non-active hay fever is
- •acceptable).
- •13. Loss or donation of blood over 500 mL within three months (males) or four
- •months (females) prior to screening or intention to donate blood or blood
- •products during the study.
- •14. If a woman, pregnant, or breast-feeding, or planning to become pregnant
- •during the study.
- •15. Any known factor, condition, or disease that might interfere with treatment
- •compliance, study conduct or interpretation of the results such as drug or
- •alcohol dependence or psychiatric disease.
- •16. Any tattoos, body modifications or other impediments to imaging present in
- •areas to be assessed, i.e. right and left arm and back.
研究者
相似试验
已完成
不适用
A Phase I, open label trial in healthy subjects to evaluate the central nervous receptor occupancy of pipamperone at the 5-HT2A and D2 receptor by means of Positron Emission Tomography.major depressive disorder10027946depressionNL-OMON34843PharmaNeuroBoost NV10
暂停
1 期
Drug interaction assessment of GSK3882347 in healthy participants aged 18 to 65 yearsHealthy volunteer drug interaction studyISRCTN16147016GlaxoSmithKline (United Kingdom)30
已完成
1 期
An open label, single dose, phase I pilot study to determine the pharmacokinetic, safety and tolerability profiles of oxymorphone delivered from a transdermal oxymorphone patchTo promote pain relief, tested in healthy volunteers.Anaesthesiology - Pain managementACTRN12613000085774Phosphagenics Limited12
已完成
1 期
An open label, phase I single application study to determine the pharmacokinetic, safety and tolerability profiles of oxycodone delivered from a transdermal oxycodone patch.ACTRN12613000398707Phosphagenics Limited12
已完成
不适用
A phase I open-label clinical trial, evaluating the therapeutic vaccine hVEGF26-104/RFASE in patients with advanced solid tumorsadvanced cancerAdvanced solid tumor10027655NL-OMON47883Vrije Universiteit Medisch Centrum27