DRKS00000293已完成1 期
Kinetics of terizidone and cycloserine after a single dose of 250 mg and after multiple-dose administration of 3 x 250 mg to healthy volunteers
适应症
试验速览
- 阶段
- 1 期
- 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
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •male and female volunteers, aged 18-45 years
- •Caucasian origin
- •BMI >= 19 kg/m² and <= 27 kg/m²
- •good health as evidenced by the results of the clinical examination and the laboratory check-up which are judged by the clinical investigator not to differ in a clinical relevant way from the normal state
- •written informed consent given by volunteer after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug
排除标准
- •results of the medical examination or laboratory screening which are judged by the clinical investigator to differ in a clinically relevant way from the normal state
- •female subjects of childbearing potential not willing to use a combination of e.g. hormonal and barrier methods of contraception during the study period (i.e. abstinence, oral contraception,
- •intrauterine device, diaphragm, condom, spermicide, implant contraception, systemic contraception) or have secondary infertility or whose partner had a vasectomy, or female subjects of non childbearing potential (i.e. had hysterectomy, bilateral ovariectomy, tube ligation) or are post-menopausal defined as absence of menstrual bleeding for 1 year, or 6 month if laboratory confirmation of hormonal status
- •volunteers with existing cardiac or hematological diseases and/ or pathological findings which might interfere with safety, pharmacodynamic effect and/ or pharmacokinetics of terizidone
- •volunteers with existing gastrointestinal diseases and/ or pathological findings which might interfere with safety, pharmacodynamic effect and/ or pharmacokinetics of terizidone
- •acute or chronic diseases which could affect drug absorption or metabolism
- •volunteers with hepatic and/or pancreas diseases
- •volunteers with renal diseases
- •volunteers liable to orthostatic dysregulation, fainting, or blackout
- •volunteers with known allergic reactions to the investigational products and their adjuvants
- •volunteers positive of HBsAG, HIV and /or drugs
- •volunteers with a history of drug addiction and alcohol dependency
- •high grade cerebral sclerosis
- •history of existing psychic / mental disorders (depressions, other psychotic disorders)
- •breast feeding mothers, lactation
- •alcohol consumption more than 20 g/day
- •special or uniform nutritional habits, e.g. vegetarians or undercaloric diet
- •intake of grapefruit containing food or beverages and poppy seeds containing products will not be allowed 14 days prior to the first drug administration and until the last blood sampling of the study
- •volunteers with uncommon physical exercise (competitive athletes), excessive physical activity one week before the trial
- •excessive smoking (more than 10 cigarettes or equivalents per day)
- •less than 14 days after last acute disease
- •less than 14 days after last systemic or local drug administration or less than 10 half-lives of the respective drugs
- •blood donation within the last 3 months
- •blocking time due to another clinical trial with investigational products
- •volunteers suspected or known not to follow instructions
- •volunteers who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
研究者
相似试验
进行中（未招募）
不适用
Investigation of the blood levels of selected antibiotics in critically ill patients undergoing dialysisSepsis and acute renal failure (ARF) are pathological entities that commonly co-exist in patients admitted to intensive care. Antibiotic dosing in septic patients with ARF can be complicated and may result in either underdosing, causing treatment failure and antibiotic resistance, or overdosing resulting in drug toxicity. The aim of this study is to collect pharmacokinetic data for evaluating underdosing or overdosing of linezolid and meropenem in patients receiving renal replacement therapy.EUCTR2013-000899-16-DEDepartment of Pharmacy Unversitätsmedizin Mainz
已完成
3 期
The effect of Terazosin and Tolterodine in the treatment of double J stent-related urinary symptomsIRCT20160924029935N2Mashhad University of Medical Sciences80
进行中（未招募）
1 期
The effects of combination treatment for panicDSM-IV Panic disorderMedDRA version: 14.1 Level: HLT Classification code 10068300 Term: Panic attacks and disorders System Organ Class: 100000004873EUCTR2012-003191-39-GBniversity of Oxford33
招募中
1 期
Single dose study of febuxostat (80 mg) in healthy subjects.Chronic goutMusculoskeletal - Other muscular and skeletal disordersACTRN12617001346369St Vincent's Hospital, Sydney10
已完成
不适用
The effect of body weight on rivaroxaban disposition in healthy human volunteersRivaroxaban disposition in healthy human volunteers (obese vs non-obese population)ISRCTN12520248Qatar University36