To evaluate the single-dose and steady-state pharmacokinetics of desloratadine and fexofenadine in desloratadine slow metabolizers. To evaluate the safety and tolerability of desloratadine compared to fexofenadine following single and multiple oral doses administered to desloratadine slow metabolizers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
220
Sanofi-Aventis
Bridgewater, New Jersey, United States
Endpoints will be the AUC and Cmax for desloratadine, 3-OH desloratadine, and fexofenadine.
Time frame: Serial, Trough, and Terminal blood samples over 8 days.
Endpoints will include Tmax, elimination half-life (t1/2), and accumulation index, as the data permit.
Time frame: Serial, Trough, and Terminal blood samples over 8 days.
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