This is a single center, single blind, single dose, randomized, partial cross-over study to confirm bioequivalence between levocetirizine and cetirizine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
20
GSK Investigational Site
Kagoshima, Japan
AUC0-48 of levocetirizine
Area Under the time-concentlation curve
Time frame: predose,0.25,0.5,1,1.5,2,3,4,6,9,12,16,24,36, 48 hours post-dose
Cmax of levocetirizine
maximum concentration
Time frame: predose,0.25,0.5,1,1.5,2,3,4,6,9,12,16,24,36, 48 hours post-dose
Number of Adverse events
Time frame: predose,1,24 48 hours post-dose
Changes in clinical laboratory tests
Time frame: predose,24,48 hours post-dose
Changes in vital signs
Time frame: predose,1,24,48 hours post-dose
Changes in 12-lead ECG.
Time frame: predose,1,24,48 hours post-dose
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