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Human Mass Balance Study With Bilastine

2014-08-27 03:34:34 | BioPortfolio

Summary

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

Description

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 Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Conditions

Healthy

Intervention

[14C]-bilastine

Location

Charles River Laboratories Clinical Services Ltd, Origo Centre
Riccarton
Edinburgh
United Kingdom
EH14 4AP

Status

Completed

Source

Faes Farma, S.A.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:34:34-0400

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Bilastine and Montelukast in Patients With Seasonal Allergic Rhinoconjunctivitis and Asthma: Efficacy of Concomitant Administration

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