Nicotinic Acid – Pharmacokinetics, Pharmacodynamics, Receptor Expression

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional

Interventions

  • Drug: nicotinic acid

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Heidelberg University
  • Overall Official(s)
    • Gerd Mikus, MD Bsc, Principal Investigator, Department Internal Medicine VI
  • Overall Contact(s)
    • Brigitte Tubach, R:N:, brigitte.tubach@med.uni-heidelberg.de

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