NCT01258491

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Nicotinic Acids

Timeline

• Start date: 2005-05-01
• Primary completion: 2005-11-01
• Completion: 2005-12-01
• First posted: 2010-12-13
• Last updated: 2010-12-13