Clinical Trial: A Study of Inhaled Atropine Sulfate in Healthy Adults

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Development of an Inhaled, Dry Powder Delivery System for the Administration of Atropine Sulfate

Brief Summary: MicroDose Defense Products, LLC is developing an atropine dry powder inhaler (ADPI). This pilot study compares the pharmacokinetics (PK) of inhaled dry powder atropine as delivered by the ADPI to atropine delivery from the AtroPen autoinjector.

Detailed Summary:
Sponsor: MicroDose Defense Products L.L.C.

Current Primary Outcome: To characterize pharmacokinetic endpoints for atropine dry powder inhalation (Cmax, Tmax, AUC) and compare these to intramuscular pharmacokinetics (Atropen autoinjector) [ Time Frame: Multiple plasma samples collected up to 12 hours post dose ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To evaluate the safety and tolerability of atropine dry powder inhalation (Clinical Labs testing, Pulse, Pulse Oximetry, Temperature, Heart Rate, Pulmonary Function Tests, Respiratory Rate, Near Point of Accommodation, Pupil Size). [ Time Frame: up to 36 days (including 14 day screening period) ]

Original Secondary Outcome: Same as current

Information By: MicroDose Defense Products L.L.C.

Dates:
Date Received: July 22, 2009
Date Started: August 2009
Date Completion:
Last Updated: August 10, 2010
Last Verified: August 2009