A Phase 1 interventional study of Bilastine and Bilastine in Healthy, sponsored by Faes Farma, S.A.. Completed at 1 site in Spain. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-26.
Sponsored by Faes Farma, S.A. · Phase 1, Interventional, and Basic science
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.
Single centre, open label, cross-over, randomised, controlled, single dose study. The primary endpoint is the determination of plasma concentrations versus time (17 samples per subject at various time intervals after dosing) in order to assess the oral bioavailability of bilastine in healthy volunteers. Therefore the primary pharmacokinetic variable will be the area under the plasma concentration versus time curve from time zero to infinity (AUC 0-∞). Additionally the following pharmacokinetic variables will also be assessed: Cmax, AUC 0-t, tmax, Ae, Clr, t1/2. Additional objectives are to describe the safety and tolerability of a single administration of oral and endovenous bilastine in healthy volunteers.
Twelve healthy volunteers will be included. Each volunteer will take in random order one single dose of 20 mg oral bilastine and 10 mg IV bilastine with a minimum washout period of 14 days between them.
Bilastine plasma concentrations will be measured using a liquid chromatography/mass mass spectrometry (LC/MS/MS) micro method
Faes Farma, S.A. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Single dose 20 mg bilastine oral tablet. Test drug
Drug: Bilastine
Single dose 10 mg Bilastine endovenous. Control drug
Drug: Bilastine
20 mg oral tablet
10 mg endovenous bilastine
The area under the plasma concentration versus time curve from time zero to infinity (AUC 0-∞ ).
Bilastine bioavailability will be obtained from the oral AUC 0-∞ / endovenous AUC 0-∞ quotient.
Time frame: 17 blood draws performed at: 0,25 - 0,5- 0,75 - 1 - 1,25 - 1,5 - 1,75 - 2 - 2,5 - 3 - 4 - 5 - 7 - 12 - 24 - 48 and 72 hours post administration.
Additional pharmacokinetic variables: Cmax, AUC 0-t, tmax, Ae, CLr and t ½
* Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval * tmax: The time that Cmax was observed * AUC 0-t: The area under the plasma concentration versus time curve from time zero to the last time point * Ae: amount of accumulated unaltered drug in urine till the last time point * Clr: Renal clearance * t ½: Elimination halflife
Time frame: 17 blood draws and urine collection during 72 hours post administration
Safety and tolerability of a single dose administration of oral and endovenous bilastine
Safety will be assessed during the study by monitoring adverse events (AEs), clinical laboratory test results (urinalysis, blood chemistry, and haematology), vital signs (including blood pressure, respiration, temperature, and heart rate, supine and standing), electrocardiogram (ECG) results, and abnormal findings upon physical examination.
Time frame: A last Follow up visit will be performed 7 days after last drug intake
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Faes Farma, S.A.