A Pharmacokinetic Evaluation Study in Healthy Volunteers
This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: September 13, 2005
Last updated: November 19, 2013
Last verified: November 2013
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.
Drug: denufosol tetrasodium (INS37217)
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- plasma concentrations of INS37217
Secondary Outcome Measures:
- Pilot study - not specified
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2003 (Final data collection date for primary outcome measure)
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00210093
Merck Sharp & Dohme Corp.
||Amy Schaberg, BSN
No publications provided
ClinicalTrials.gov processed this record on October 19, 2014
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 13, 2005
||November 19, 2013
||United States: Food and Drug Administration