NCT01258491已完成1 期
Double-blind, Randomized, Placebo-controlled, Single-center, 2 Treatment, 3-way Crossover Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of a Single Oral Repeated Dose of 500 mg Nicotinic Acid as Tablets in Healthy Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
The study will be a double-blind, randomized, placebo-controlled, single-center, 2 treatment,3-way crossover to investigate the pharmacodynamics, i.e. the flush-symptom of a single oral repeated dose of 500 mg nicotinic acid in healthy subjects. Subjects will be randomly allocated to a treatment sequence - AAB, ABA or BAA. The two treatments will be:
- Treatment A: 500 mg nicotinic acid
- Treatment B: Placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight between 50 and 90 kg with a body mass index between 19 and <30 kg/m2
- •No clinically relevant findings in the medical history, laboratory examinations and physical examination, especially with regard to cardiovascular system, liver function test, bilirubin values and the skin
- •No clinical relevant pathological findings in electrocardiogram (ECG)
- •Normal blood pressure (BP, syst. 100 to 140 mmHg, diast. 60 to 90 mmHg) and pulse rate (between 50 and 90 beats/min) in sitting position
- •Voluntarily signed informed consent after full explanation of the study to the participant
排除标准
- •Treatment with any other investigational product in the last 60 days before the day of randomization into the study
- •Regular use of medication in the last 60 days before the day of randomization into the study except of oral contraceptives in female participants
- •Treatment in the 60 days before the day of randomization into the study with any drug known to have a well-defined potential for toxicity to a major organ, or any substance which is known to induce or inhibit hepatic drug metabolism (including general anesthetics)
- •Any drug intake (including over-the-counter remedies) in the 2 weeks before the day of randomization into the study, unless the investigator considers a drug intake to be clinically irrelevant for the purpose of this study
- •Any acute or chronic illness or clinically relevant findings in the pre-study examination
- •Presence, history or sequelae of gastrointestinal (e.g. peptic ulcer), liver or kidney disease, or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
- •History of hypersensitivity to the investigational product
- •History or presence of abnormalities of the vascular bed
- •History or presence of a dermatologic disease or skin lesions, particular in the area chosen for flush measurement
- •History of allergy or hypersensitivity to other drugs or to food constituents
- •History of other allergic diseases or hypersensitivity, unless the investigator considers it to be clinically irrelevant for the purpose of this study
- •Blood donation of >400 ml in the 60 days before the day of randomization into the study
- •Positive result in urine screen for drugs of abuse or in alcohol breath test
- •Known or suspected to be drug-dependent, including consumption of >30 g alcohol per day
- •Pregnancy or lactation
研究者
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