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Completed

NCT Number: NCT00944645

MK0524A Bioequivalence Study (0524A-059)

This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is in good health
  • Subject is willing to follow all study guidelines

Exclusion criteria

  • Subject has or has a history of any disease or condition that might confound the results of the study or make participation unsafe

Treatment and study plan

niacin (+) laropiprant (Source 1)

Drug

Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods.

Comparator: niacin (+) laropiprant (Source 2)

Drug

Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 2 in one of two treatment periods.

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of Nicotinuric Acid

    Time frame: Predose and up to 24 hours postdose

    Measure of rate of absorption of ER niacin

  2. Total Amount of Urinary Excretion of Niacin and Its Metabolites

    Time frame: Predose and up to 96 hours postdose

    Measure of extent of absorption of ER niacin

  3. Area Under Curve (AUC 0-infinity) of Laropiprant

    Time frame: Predose and up to 48 hours postdose

    Measure of extent of absorption of laropiprant

  4. Maximum Concentration (Cmax) of Laropiprant

    Time frame: Predose and up to 48 hours postdose

    Measure of rate of absorption of laropiprant

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open Label, Randomized, 2-Period, Crossover Study to Establish the Definitive Bioequivalence of Niacin and MK0524 of 2 Sources of MK0524A Tablets

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 23, 2009
Registry last updated
Jun 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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