Status:

COMPLETED

A Pharmacokinetic Evaluation Study in Healthy Volunteers

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Healthy

Phase:

PHASE1

Brief Summary

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2003

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT00210093

Start Date

April 1 2003

End Date

May 1 2003

Last Update

October 16 2015

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