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Comparison of TRIA-662 500 mg and Niaspan 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions

NCT01809301 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-08-22

No results posted yet for this study

Summary

The objective of this study is to compare the absorption of a niacin metabolite (1-methylnicotinamide, 1-MNA) from TRIA-662 (1-methylnicotinamide chloride)relative to the production of 1-MNA from Niaspan. The 1-MNA information obtained from this study will be used to adjust the top dose of a planned TRIA-622 efficacy study.

Conditions

  • Healthy

Interventions

DRUG

Niaspan

DRUG

TRIA-662

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Pharmena North America

    collaborator INDUSTRY

  • Cortria Corporation

    lead INDUSTRY

Principal Investigators

  • Eugenio A Cefali, PharmD, PhD. · Cortria Corporation

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Canada

Study Locations

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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 NCT01809301 on ClinicalTrials.gov