Healthy
Conditions
Keywords
nicotinic acid, flush symptom, pharmacodynamic, pharmacokinetic
Brief summary
The study will be a double-blind, randomized, placebo-controlled, single-center, 2 treatment, 3--way crossover. Subjects will be randomly allocated to a treatment sequence - AAB, ABA or BAA. The two treatments will be: * Treatment A: 500 mg nicotinic acid (Niacor(R)) * Treatment B: Niacor(R) Placebo Each trial period will last one day, there will be a wash-out period of at least 2 days between each trial period. Five to seven days after study day 1 of trial period 3 there will be a final safety examination.
Interventions
DRUGnicotinic acid
Sponsors
Heidelberg University
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Good state of health physically and mentally
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 * Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol * Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study * Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Contacts
Primary ContactBrigitte Tubach, R:N:
Outcome results
None listed