drugset / Trial / NCT00572611
Human Mass Balance Study With Bilastine
Phase 1
Completed
6 enrolled
Faes Farma, S.A.
Charles River Clinical Services Edinburgh Ltd and CR Laboratories Preclinical Services Ltd · collabMDS Pharma Services Switzerland AG · collab
NaSingle-groupOpen-labelBasic science
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
Timeline
- Start
- 2007-11
- Primary completion
- 2007-12
- Completion
- 2007-12
Publications
- Background Lucero ML, Gonzalo A, Mumford R, Betanzos M, Alejandro A. An overview of bilastine metabolism during preclinical investigations. Drug Chem Toxicol. 2012 Jun;35 Suppl 1:18-24. doi: 10.3109/01480545.2012.682651.
- Background Lucero ML, Patterson AB. Whole-body tissue distribution of total radioactivity in rats after oral administration of [(1)(4)C]-bilastine. Drug Chem Toxicol. 2012 Jun;35 Suppl 1:1-7. doi: 10.3109/01480545.2012.682650.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bilastine | Small molecule | 20 mg | Oral |
Indications
No indication recorded.