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Human Mass Balance Study With Bilastine

NCT00572611 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2012-09-26

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

DRUG

[14C]-bilastine

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

Sponsors & Collaborators

  • Charles River Clinical Services Edinburgh Ltd and CR Laboratories Preclinical Services Ltd

    collaborator UNKNOWN

  • MDS Pharma Services Switzerland AG

    collaborator UNKNOWN

  • Faes Farma, S.A.

    lead INDUSTRY

Principal Investigators

  • Stuart J Mair, MD · Syneos Health

  • Lindsay McGregor · Syneos Health

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00572611 on ClinicalTrials.gov