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Comparator Study of LT-NS001 in Healthy Subjects With Endoscopic Evaluation

NCT00750243 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2010-10-06

No results posted yet for this study

Summary

The purpose of this study is to compare naproxen plasma levels and gastroduodenal mucosal injury after administration of LT-NS001 as compared to Naprosyn in subjects age 45-70.

Conditions

  • Healthy

Interventions

DRUG

LT-NS001

1200 mg b.i.d. p.o. for 7.5 days

DRUG

Naprosyn®

500 mg b.i.d. p.o. for 7.5 days

Sponsors & Collaborators

  • Logical Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-02-28
Completion
2009-04-30

Countries

  • United States

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 NCT00750243 on ClinicalTrials.gov