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Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of a Single Oral Repeated Dose of 500 mg Nicotinic Acid as Tablets in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01258491
First received: December 10, 2010
Last updated: NA
Last verified: December 2005
History: No changes posted

December 10, 2010
December 10, 2010
May 2005
November 2005   (final data collection date for primary outcome measure)
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No Changes Posted
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Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of a Single Oral Repeated Dose of 500 mg Nicotinic Acid as Tablets in Healthy Subjects
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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Basic Science
Healthy Subjects
Drug: Nicotinic Acids
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
December 2005
November 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01258491
K115
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Prof. Dr. Gerd Mikus, University Hospital
Heidelberg University
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Heidelberg University
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP