A Pharmacokinetic Evaluation Study in Healthy Volunteers

This study has been completed.

First Received: September 13, 2005 Last Updated: September 20, 2005 History of Changes

Sponsored by:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00210054

Purpose

The purpose of this trial is to characterize the pharmacokinetics of INS37217 following intravenous administration.

Condition	Intervention	Phase
Healthy	Drug: denufosol tetrasodium (INS37217)	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Pilot Single-Dose Intravenous Pharmacokinetic Evaluation of INS37217 Solution in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Denufosol INS37217

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	4
Study Start Date:	November 2002

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

history or suspicion of recent alcohol, barbiturate, amphetamine or narcotic abuse or a positive urine drug test at study screening
history of cardiac arrhythmias, bronchospastic or cardiovascular disease, diabetes mellitus, thyrotoxicosis, Parkinsonism, or drug allergy
use of concomitant medication other than hormonal contraceptives and multi-vitamins
donation of blood in the 60 days preceding the screening visit
have been diagnosed with HIV, hepatitis B or hepatitis C

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210054

Sponsors and Collaborators

Inspire Pharmaceuticals

Investigators

Principal Investigator:

Robin Deterding, MD

Unaffiliated

More Information

No publications provided

Study ID Numbers:	08-105
Study First Received:	September 13, 2005
Last Updated:	September 20, 2005
ClinicalTrials.gov Identifier:	NCT00210054 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 02, 2009