NCT00572611

Human Mass Balance Study With Bilastine

A Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Bilastine Following Oral Administration to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Faes Farma, S.A. · Industry
• Sex: Male
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	[14C]-bilastine	Single oral dose of 20 mg \[14C\]-bilastine. 1 capsule. 1 day dosing only

Timeline

• Start date: 2007-11-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-12-13
• Last updated: 2012-09-26

Locations

1 site across 1 country: United Kingdom