NL-OMON48026已完成不适用
A randomized, single-blinded, 3-way cross-over trial to investigate the pharmacokinetics of sustained release cysteamine bitartrate (PO-001) in healthy adult volunteers. - Cysteamine bitartrate PO-001
Patient One0 个研究点目标入组 9 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
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
- •Subjects must meet all of the following criteria to be considered eligible to
- •participate in the study:
- •1. Healthy male, and 18-55 years of age (inclusive);
- •2. Body Mass Index between 18 and 27 kg/m2 (inclusive) and body weight minimal
- •50 kg (inclusive);
- •3. Ability to read and understand the written consent form, complete
- •study-related procedures, and communicate with the study staff;
- •4. All males must practice effective contraception during the study and be
- •willing and able to continue contraception for at least 90 days after their
- •last dose of study treatment;
- •5. Subjects must be able to swallow the drug-administered capsules with the
- •capsule intact;
- •6. Willingness to comply with study restrictions and requirements.
排除标准
- •Subjects are not allowed to participate in the study if any of the following
- •exclusion criteria apply:
- •1. Clinically relevant abnormal history or presence of physical and mental
- •health as determined by medical history taking and physical examinations
- •obtained during the screening visit and/or at the start of the first study day
- •(as judged by the investigator);
- •2. Clinically relevant abnormal laboratory results, ECG and vital signs at
- •screening and/or at the start of the first study day (as judged by the
- •investigator);
- •3. Acute disease state (e.g. nausea, vomiting, fever, or diarrhea) within 7
- •days before the first study day;
- •4. Abnormal renal function (eGFR (MDRD) < 60 mL/min/1.73m2);
- •5. Positive test for hepatitis B, C or HIV at screening;
- •6. 6. History of alcoholism or substance abuse within three years prior to
- •screening or current use of more than 21 units alcohol per week or drug abuse;
- •7. Subjects using, on average, more than 3 units of alcohol per day, and unable
- •to refrain from alcohol use from 24 hours prior to screening, each study day
- •and whilst in study unit;
- •8. Subjects smoking, on average, more than 5 cigarettes per day, and unable to
- •refrain from smoking during the study days;
- •9. Positive drug- (i.e. positive for cocaine, opioids, amphetamines, opiates,
- •cannabinoids, benzodiazepines, and/or methadone) or alcohol test at screening
- •and/or first study day;
- •10. Inability to refrain from the use of concomitant (prescription and over the
- •counter) medication which, in the opinion of the investigator, interferes with
- •their ability to participate in the trial, from one week (or less than 5
- •half-lives (whichever is longer) prior to the first the first study day until
- •the last study day;
- •11. Use of any dietary supplements within 7 days of study drug administration,
- •or less than 5 half-lives (whichever is longer). Exceptions can be made as
- •judged by the investigator;
- •12. A history of severe allergies, or has had an anaphylactic reaction or
- •significant intolerability (hypersensitivity) to prescription or
- •non-prescription drugs or food;
- •13. Hypersensitive (allergic) to cysteamine (mercaptamine) or any of the other
- •ingredients, e.g. to penicillamine;
- •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 drug;
- •15. Participation in an investigational drug study within 90 days prior to
- •screening or more than 4 times a year;
- •16. Loss or donation of blood over 500 mL within 90 days prior to screening or
- •intention to donate blood or blood products during the study;
- •17. Inadequate venous accessibility as judged by the physician or nurse;
- •18. Any known factor, condition, or disease or any reason that might interfere
- •in the opinion of the medical responsible person with the well-being of the
- •subject, treatment compliance, study conduct or interpretation of the results.
研究者
相似试验
尚未招募
不适用
Cysteamine bitartrate PO-001CystinosisNL-OMON26870Patient One9
进行中（未招募）
1 期
It is the aim of this study to analyse the blood flow in small blood vessels (capillaries) in diabetic patients before and after two different single doses of BAY 1193397 (1 mg and 5 mg tablets) and placebo. In order to see if the study drug is effective, BAY 1193397 tablets will be compared to placebo tablets.Treatment of diabetic foot ulcerMedDRA version: 20.0 Level: LLT Classification code 10012684 Term: Diabetic peripheral vascular disease System Organ Class: 100000004866EUCTR2015-003799-63-GBBayer AG22
已完成
不适用
A double-blind, randomized, three-way cross-over trial to develop a pharmacologic challenge with ketamine.schizophreniapsychotic disorder10039628NL-OMON34124Centre for Human Drug Research24
已完成
不适用
A randomized, double-blind, three-way crossover study to compare the pharmacokinetics, pharmacodynamics and safety of a single 6 mg subcutaneous administration of the<br>proposed biosimilar product LA-EP2006, Neulasta® US and Neulasta® EU in healthy subjectsinfectionreduced white blood cell count10018849NL-OMON45253Hexal AG136
已完成
1 期
A programme to develop a skin patch containing two medicines (physostigmine and hyoscine), Study 1: Assessment of blood levels of the two medicines and any associated symptoms in healthy male participants wearing prototype skin patchesISRCTN21827000Dstl18