A Pharmacokinetic Evaluation Study in Healthy Volunteers
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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.
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
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Ages Eligible for Study:
Child, Adult, Older Adult
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