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MK0524A Bioequivalence Study (0524A-059)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dyslipidemia

Intervention: niacin (+) laropiprant (Source 1) (Drug); Comparator: niacin (+) laropiprant (Source 2) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Maximum Plasma Concentration (Cmax) of Nicotinuric Acid

Total Amount of Urinary Excretion of Niacin and Its Metabolites

Area Under Curve (AUC 0-infinity) of Laropiprant

Maximum Concentration (Cmax) of Laropiprant

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: October 2006
Last updated: May 25, 2015

Page last updated: August 23, 2015

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