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A Pharmacokinetic Evaluation Study in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00210093
First received: September 13, 2005
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

The purpose of this trial is to characterize the pharmacokinetics of INS37217 following intravenous, intranasal, and inhalation administration and to calculate the relative bioavailability of INS37217 when administered via oral or nasal inhalation.


Condition Intervention Phase
Healthy
Drug: denufosol tetrasodium (INS37217)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Center, Randomized, Crossover Pharmacokinetic Evaluation of the Effect of Single Doses of Intravenous INS37217, Nasally Inhaled INS37217 and Orally Inhaled INS37217 Solution in Healthy Volunteers

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • plasma concentrations of INS37217

Secondary Outcome Measures:
  • Pilot study - not specified

Enrollment: 12
Study Start Date: April 2003
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
  Eligibility

Criteria

Inclusion Criteria:

  • Are current nonsmokers or previous smokers who have not smoked within 6 months and who do not have greater than or equal to a 10 pack-year history of tobacco use
  • Are within 20% of their ideal body weight
  • Are healthy on the basis of a pre-trial physical examination

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, any pathological abnormality on the ECG, bronchospasm, diabetes mellitus, thyrotoxicosis, Parkinsonism, asthma, COPD or cardiovascular disease significant drug allergy
  • Subject with a physical obstruction in the nose
  • Use of concomitant medication other than hormonal contraceptives and multi-vitamins
  • Subjects with a current upper respiratory illness or infection for the 2 weeks prior to screening or any chronic respiratory illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210093

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Amy Schaberg, BSN
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00210093     History of Changes
Other Study ID Numbers: 08-106
Study First Received: September 13, 2005
Last Updated: October 27, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 25, 2014