NCT00909519

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

A Phase 1, Single-Center, Randomized, Parallel-group, Placebo- and Naproxen- Controlled, Double-blind Study to Evaluate the Effect of Naproxcinod 750 mg Bid Administered for 8 Days on the Renal Hemodynamics, Natriuretic and Renin Responses to a Single Bolus IV Dose of Furosemide 40 mg in Male Healthy Normotensive Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: NicOx · Industry
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	naproxcinod	naproxcinod 750 mg bid
DRUG	Naproxen	Naproxen 500 mg bid
DRUG	placebo	placebo
DRUG	furosemide	furosemide

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2009-05-28
• Last updated: 2011-06-17