This is a single-center, two-period, randomized, open-label, crossover pharmacokinetic (PK) study in healthy adult volunteers to evaluate dose proportionality of diazepam nasal spray using two dose levels
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
diazepam nasal spray at two dose levels (DL). One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
Site #001
Dallas, Texas, United States
Maximum measured plasma concentration (Cmax)
Time frame: within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
Area under the concentration curve from time 0 to the concentration at 24 hours (AUC0-24)
Time frame: within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
Area under the concentration curve from time 0 to infinity (AUCinf)
Time frame: within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
Apparent total body clearance of drug from plasma (CL/F)
Time frame: within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
Number of patients with adverse events (AEs) including serious AEs
Time frame: up to 21 days
Change in focused nasal exam
Time frame: within 30 minutes prior to dosing and at specified time points up to 24 hours post-dose
Taste change questionnaire
If patient reports a change in taste associated with diazepam nasal spray, questionnaire to be completed by research staff.
Time frame: from 5 minutes up to 24 hours post-dose
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