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Sponsors and Collaborators: |
Faes Farma, S.A. Charles River Clinical Services Edinburgh Ltd Charles River Laboratories Preclinical Services Ltd MDS Pharma Services Switzerland AG Kendle International |
Information provided by: | Faes Farma, S.A. |
ClinicalTrials.gov Identifier: | NCT00572611 |
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
Condition | Intervention | Phase |
Healthy |
Drug: [14C]-bilastine |
Phase I |
Drug Information available for: | Bilastine |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Bilastine Following Oral Administration to Healthy Volunteers |
Estimated Enrollment: | 6 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2007 |
Arms | Assigned Interventions |
I: Experimental
Single oral dose of 20 mg [14C]-bilastine
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Drug: [14C]-bilastine
Single oral dose of 20 mg [14C]-bilastine. 1 capsule. 1 day dosing only
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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.
Ages Eligible for Study: | 30 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lindsay McGregor, Study director | +44 (0) 1875 614545 | Lindsay.McGregor@eur.crl.com |
Contact: Penny Forster, Project Manager | +44 (0) 1875 614545 | Penny.Forster@crl.com |
United Kingdom, Edinburgh | |||||
Charles River Laboratories Clinical Services Ltd, Origo Centre | Recruiting | ||||
Riccarton, Edinburgh, United Kingdom, EH14 4AP | |||||
Principal Investigator: Stuart J Mair, MD | |||||
Sub-Investigator: Janet Dickson, MD |
Faes Farma, S.A. |
Charles River Clinical Services Edinburgh Ltd |
Charles River Laboratories Preclinical Services Ltd |
MDS Pharma Services Switzerland AG |
Kendle International |
Principal Investigator: | Stuart J Mair, MD | Charles River Clinical Services Edinburgh Ltd |
Study Director: | Lindsay McGregor | Charles River Laboratories Preclinical Services Ltd |
Responsible Party: | Charles River Clinical Services Edinburgh Ltd ( Dr Stuart Mair, Principal Investigator. Medical Advisor ) |
Study ID Numbers: | BILA 459-13, EudraCT Number: 2007-003373-12, CR Study Number: 186781 |
First Received: | December 12, 2007 |
Last Updated: | December 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00572611 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Administration of Radioactive Substances Advisory Committee |
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