A Study of Inhaled Atropine Sulfate in Healthy Adults (NCT00947596) | Clinical Trial Compass
CompletedPhase 1
A Study of Inhaled Atropine Sulfate in Healthy Adults
United States18 participantsStarted 2009-08
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* Subjects will be 18-55 years of age.
* Subjects will be able to read and comprehend the English language.
Exclusion Criteria:
* Subjects weighing less than 100 lbs.
* Women of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with positive pregnancy testing on either screening day or any test day will be excluded. Nursing mothers will be excluded
* Persons unable or unwilling to complete written informed consent (No proxy consent will be obtained).
* Persons with a past medical history or symptoms of pulmonary disease (including but not limited to: asthma, COPD, Emphysema, Sarcoidosis, Lung Cancer, Pulmonary Embolism, Pulmonary Hypertension))or cardiac disease (coronary artery disease, hypertension, angina, arrhythmias, palpitations, past myocardial infarction history).
* Persons with a previous history or symptoms of adverse reaction to atropine.
* Persons with history or symptoms of prostate hypertrophy or prostate cancer.
* Persons with a history or symptoms of pyloric stenosis.
* Persons with a history or symptoms of high blood pressure or a diagnosis of cerebral vascular accident (CVA) or transient ischemic attack (TIA).
* Subjects with a history or symptoms of urological disorders or renal insufficiency.
* Subjects with a history or symptoms of diabetes.
* Persons demonstrating increased intraocular pressure, an abnormal optical exam, or history of glaucoma.
* Persons demonstrating a one second forced exp…
What they're measuring
1
To characterize pharmacokinetic endpoints for atropine dry powder inhalation (Cmax, Tmax, AUC) and compare these to intramuscular pharmacokinetics (Atropen autoinjector)
Timeframe: Multiple plasma samples collected up to 12 hours post dose