The primary objective of the study is to define the absorption and excretion kinetics of bilastine in man following oral administration, and to investigate the nature of the metabolites present in plasma and excreta. The secondary objective of the study is to assess the safety and tolerability of bilastine
Primary Endpoints are: Whole blood and plasma concentrations of total radioactivity and parent drug. Urine and faecal recovery of total radioactivity. Characterisation and identification of metabolites in plasma, urine and faeces.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
Single oral dose of 20 mg \[14C\]-bilastine. 1 capsule. 1 day dosing only
Charles River Laboratories Clinical Services Ltd, Origo Centre
Riccarton, Edinburgh, United Kingdom
Whole blood and plasma concentrations of total radioactivity and parent drug
Time frame: 168-216 h after dosing, depending on the radioactivity recovery
Urine and faecal recovery of total radioactivity
Time frame: 168-216 h after dosing, depending on the radioactivity recovery
Characterisation and identification of metabolites in plasma, urine and faeces
Time frame: 168-216 h after dosing, depending on the radioactivity recovery
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