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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

NCT01258491 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2010-12-13

No results posted yet for this study

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 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

Conditions

  • Healthy Subjects

Interventions

DRUG

Nicotinic Acids

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2005-11-30
Completion
2005-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01258491 on ClinicalTrials.gov