NL-OMON50731已完成不适用
Interventional study to assess local pharmacodynamics and tolerability of topical allyl isothiocyanate in healthy male subjects. - AITC model validation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
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 and *65 years of age.
- •2. Signed informed consent before any study procedures.
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
- •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 drug administration, or less than 5 half-lives (whichever is
- •longer). Paracetamol (up to 4 g/day) and ibuprofen (up to 1g/day) are not
- •allowed within 2 days before screening and before each study drug
- •administration. 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 drug 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 other investigational drug or device study (last dosing of
- •previous study was within 90 days prior to first dosing of this study or dosed
- •>3 times in the year 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 24 hours before screening or study days.
- •10. Smoking (i.e., smoking of any cigarettes within 3 months of study
- •participation). Minor deviations may be accepted if judged by the investigator
- •to have no clinical relevance.
- •11. Excess of caffeine consumption (more than eight cups of coffee or
- •equivalent per day)
- •12. Known allergy to mustard oil, or any confirmed significant allergic
- •reactions (urticaria or anaphylaxis) against any drug or food component, or
- •multiple drug allergies (non-active hay fever is acceptable), or (history of)
- •contact allergies, or history of atopic dermatitis, or history of food
- •13. Loss or donation of blood over 500 mL within three months prior to
- •screening or intention to donate blood or blood products during the study.
- •14. 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.
- •15. Any skin disorders, excessive hair growth, tattoos, or other phys
研究者
相似试验
招募中
不适用
Clinical pharmacy services to improve management outcomes of Chronic Kidney Disease of uncertain etiology patients undergoing hemodialysisChronic Kidney Disease of uncertain etiologySLCTR/2018/011ational Science Foundation
已完成
不适用
A clinical study to investigate the pharmacokinetic-pharmacodynamic model of propofol after intravenous administration of propofol in children patientsKCT0000521Seoul National University Hospital40
招募中
Unknown
A clinical study to investigate the pharmacokinetics of [11C]K-2 in healthy volunteers.JPRN-jRCT1031230235Abe Hiroki5
尚未招募
1 期
Clinical study of Darvyadi Granules in Iron Deficiency Anaemia.CTRI/2020/04/024459Parul University
进行中（未招募）
不适用
A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid ArthritisEUCTR2012-000535-36-CZAbbott GmbH & Co. KG100