Healthy Subjects
Conditions
Brief summary
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
Interventions
DRUGNicotinic Acids
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * Smoking * 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
Outcome results
None listed