Healthy Volunteers Clinical Trial
Official title:
ADASUVE®-Lorazepam Drug-Drug Interaction Study
This study will compare the safety and effects over time for giving both ADASUVE and lorazepam (intramuscular) compared to that of each agent given alone.
The objective of this study is to compare the safety and pharmacodynamic profiles of
concomitant administration of a single dose of ADASUVE and lorazepam (IM) compared to that of
each agent administered alone. Respiratory pharmacodynamics will be monitored through
recordings of respirations/minute and pulse oximetry. Other pharmacodynamic safety measures
will include effects on blood pressure, heart rate, sedation and psychomotor measures of
attention, information processing speed, reaction time, and coordination.
Initially, 4 subjects will receive lorazepam 1 mg IM + ADASUVE 10 mg open label to validate
the dose regimen. After the safety data are reviewed and the dose regimen confirmed, 18
non-obese, healthy male or female volunteers between the ages of 18 and 50 will be enrolled
in this double-blinded, double-dummy, randomized, 3-period cross-over drug interaction study.
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