The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form taken without water and brotizolam conventional tablets (Lendormin® tablets) taken with water, was evaluated in healthy adult male subjects (open-labelled, 2-way cross-over study)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
AUC0-24h (Area under the plasma concentration-time from 0 to 24 hours)
Time frame: up to 24 hours after drug administration
Cmax (maximum plasma concentration)
Time frame: up to 24 hours after drug administration
Number of patients with adverse events
Time frame: up to 30 days
tmax (time to maximum plasma concentration)
Time frame: up to 24 hours after drug administration
MRT (Mean residence time)
Time frame: up to 24 hours after drug administration
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