Status:
COMPLETED
Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of a Single Oral Repeated Dose of 500 mg Nicotinic Acid as Tablets in Healthy Subjects
Lead Sponsor:
Heidelberg University
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01258491
Start Date
May 1 2005
End Date
December 1 2005
Last Update
December 13 2010
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