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Effect of Repeated Dosing of Naproxcinod on Renal Hemodynamic and on Sodium Balance in Healthy Volunteers Before and After a Single Dose of Furosemide

NCT00909519 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2011-06-17

No results posted yet for this study

Summary

This phase 1 study is an 8-day treatment period, randomized, controlled, double-blind, 3 parallel-groups, monocentric study. The primary objective is to evaluate the effect of naproxcinod on the renal function when co-administered with furosemide in comparison to naproxen and placebo.

Conditions

  • Renal Hemodynamics

Interventions

DRUG

naproxcinod

naproxcinod 750 mg bid

DRUG

Naproxen

Naproxen 500 mg bid

DRUG

placebo

placebo

DRUG

furosemide

furosemide

Sponsors & Collaborators

  • NicOx

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-04-30
Completion
2009-04-30

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Drugs

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 NCT00909519 on ClinicalTrials.gov