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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
dry powder for inhalation
intramuscular injection
Montefiore Hospital Clinical and Translational Research Center
Pittsburgh, Pennsylvania, United States
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
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)
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