Oral Bioavailability of Bilastine (BIOBI)
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|ClinicalTrials.gov Identifier: NCT01124123|
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : September 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Bilastine||Phase 1|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Study to Assess Oral Bioavailability of Bilastine (Estudio de Biodisponibilidad Oral de Bilastina)|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||September 2010|
Experimental: Bilastine 20 mg
Single dose 20 mg bilastine oral tablet. Test drug
20 mg oral tablet
Active Comparator: Bilastine 10 mg
Single dose 10 mg Bilastine endovenous. Control drug
10 mg endovenous bilastine
- The area under the plasma concentration versus time curve from time zero to infinity (AUC 0-∞ ). [ 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. ]Bilastine bioavailability will be obtained from the oral AUC 0-∞ / endovenous AUC 0-∞ quotient.
- Additional pharmacokinetic variables: Cmax, AUC 0-t, tmax, Ae, CLr and t ½ [ Time Frame: 17 blood draws and urine collection during 72 hours post administration ]
- 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
- Safety and tolerability of a single dose administration of oral and endovenous bilastine [ Time Frame: A last Follow up visit will be performed 7 days after last drug intake ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01124123
|Unidad de Investigacion Clinica. Clinica Universidad de Navarra|
|Pamplona, Navarra, Spain, 31008|
|Principal Investigator:||Belen Sadaba, MD||Unidad de Investigacion Clinica. Clinica Universidad Navarra (CUN)|