ALLERGIC RHINOCONJUNTIVIS AND CHRONIC URTICARIA
Conditions
Interventions
Trade Name: BILAXTEN
Pharmaceutical Form: Tablet
INN or Proposed INN: BILASTINE
CAS Number: 202189-78-4
Current Sponsor code: F-96221-BM1
Other descriptive name: BILASTINE
Concentration unit: mg milli
Sponsors
FAES FARMA, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Subjects of either gender (male or female) aged =18 and = 45 years at the time of the enrolment. 2 Subjects free from organic or psychic conditions. 3 Medical records and physical examination at screening normal. 4 No clinically significant abnormalities in haematology, biochemistry, serology (Ag HBs, HC, antibodies, HIV antibodies) and urine tests. 5 Vital signs and electrocardiogram record within normal range. 6 Body weight within normal range (BMI = 18.0 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 Background of allergy, idiosyncrasy or hypersensitivity to drugs or any related products (including excipients of the formulations). 2 Heavy consumer of stimulating drinks (>5 cups of coffee, tea, chocolate or cola drinks per day). 3 Background History of alcohol dependence or drug abuse in the last 5 years or daily consumption of alcohol > 40 gr/day for men or 24 gr/day for women. 4 Intake of any medication within 2 weeks prior taking the study treatment (except for use of paracetamol in short-term symptomatic treatments, according to the investigator criteria), including over-the-counter products (including natural food supplements, vitamins and medicinal plants products). 5 Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results. 6 Positive results for abuse drugs in urine test or ethanol in breath test. 7 Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, haematological, neurological disease or other chronic diseases. 8 Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. 9 Females with positive results from the pregnancy test or breast-feeding. 10 Smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, electronic cigarettes, etc.) for 6 months prior to the study medication intake. 11 To have participated in another clinical trial during the 3 months prior to study start in which an investigational drug or a commercially available drug was tested. 12 To have donated blood within the 4 weeks period before inclusion in the study. 13 Mentally or legally incapacitated at screening. 14 Unwillingness or inability to follow the procedures outlined in the protocol. 15 Any condition that, in the opinion of the investigator, may jeopardise the trial conduct according to the protocol. 16 History of difficulty in swallowing. 17 Positive dermographism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of Bilastine 20 mg administered orally under fasted and fed conditions (moderate-fat meal) in reduction of histamine-induced skin reactivity in healthy volunteers, taking into account the first treatment day (Day 1) and steady state (Day 4).;Secondary Objective: To evaluate the onset of action, duration of the effect, maximum effect and maximum effect time of the wheal & flare surface areas. To evaluate the subjective sensation of itching after histamine inoculation. To assess the safety and tolerability of bilastine after repeated (4 days) single daily oral dose (20mg) administration in young male and female healthy volunteers.;Primary end point(s): The primary endpoint will be the mean AUC0????-24 (± standard deviation) of percentages of reduction versus baseline values of the wheal and flare surface areas in each time point. The mean AUC0????-24 (± SD) will be calculated for Day 1 and Day 4 of each group, that is, under fasted and fed conditions. Baseline value: It is defined as the skin test measurements obtained before the volunteers have been exposed to the study drug, that means pre-dose assessment performed on Day 1 of each period.;Timepoint(s) of evaluation of this end point: From Day 1 up to Day 4 of each group, that is, under fasted and fed conditions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The mean values of wheal and flare surface areas expressed as percentage (%) of reduction respect to their baseline values in each time points, for Day 1 and Day 4, under fasted and fed conditions. Onset of action: the first time point (h) where wheal and flare surface areas show statistically significant differences, compared to their baseline values. Duration of the effect: last time point (h) in which the wheal and flare surface areas show statistically significant differences, compared to their baseline values. Maximum effect: maximum percentage of reduction of the wheal and flare surface areas. Maximum effect time: time point (h) in which the maximum percentage of reduction of wheal and flare surface areas is reached. Itching sensation: percentage of variation (reduction) in the VAS score versus their corresponding baseline values, in each time points and in both groups (fasting and feeding). All the parameters calculated for wheal and flare surface area values will be applied to itching sensation scores. Changes in the tolerability parameters (clinical laboratory tests, vital signs recording, ECG parameters) evaluated in terms of clinical relevance. Incidence of adverse events.;Timepoint(s) of evaluation of this end point: Antihistamine activity will be assessed by measurement of the wheal and flare area induced by histamine skin test before and after a single daily dose treatment of bilastine. Treatment in each period will last 4 days. Skin tests will be performed on Days 1 and Day 4 of each period, at the following time points: pre-dose, +0.5h, +1h, +2h, +4h, +6h, +9h, +12h, +24h. Vital signs (systolic and diastolic pressure, heart rate and axillary temperature) will be evaluated at the following time points: baseline [pre-dose], [+1h], [+4h], [+9h], [+12h], and [+24h] post-drug administration. Adverse events and concomitant medication will be monitored in a continuous way. | — |
Countries
Spain
Contacts
Public ContactClinical Research Director
FAES FARMA, S.A.
Outcome results
None listed