Healthy Subjects Clinical Trial
Official title:
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
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
Status | Completed |
Enrollment | 18 |
Est. completion date | December 2005 |
Est. primary completion date | November 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Basic Science
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Heidelberg University |
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