drugset / Trial / NCT01124123
Oral Bioavailability of Bilastine
RandomizedCrossoverOpen-labelBasic science
Summary
The purpose of this study is to assess the absolute bioavailability of an oral bilastine formulation (test drug) compared to the endovenous administration of an IV bilastine formulation (control drug) in healthy volunteers.
Timeline
- Start
- 2010-05
- Primary completion
- 2010-06
- Completion
- 2010-09
Publications
- Background Jauregizar N, de la Fuente L, Lucero ML, Sologuren A, Leal N, Rodriguez M. Pharmacokinetic-pharmacodynamic modelling of the antihistaminic (H1) effect of bilastine. Clin Pharmacokinet. 2009;48(8):543-54. doi: 10.2165/11317180-000000000-00000.
- Background Lucero ML, Gonzalo A, Ganza A, Leal N, Soengas I, Ioja E, Gedey S, Jahic M, Bednarczyk D. Interactions of bilastine, a new oral H(1) antihistamine, with human transporter systems. Drug Chem Toxicol. 2012 Jun;35 Suppl 1:8-17. doi: 10.3109/01480545.2012.682653.
- Sadaba B, Gomez-Guiu A, Azanza JR, Ortega I, Valiente R. Oral availability of bilastine. Clin Drug Investig. 2013 May;33(5):375-81. doi: 10.1007/s40261-013-0076-y.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bilastine | Small molecule | 10 mg | Oral |
| Comparator | Bilastine | Small molecule | 20 mg | Oral |
Indications
No indication recorded.