ALLERGIC RHINOCONJUNTIVITIS AND CHRONIC URTICARIA
Conditions
Interventions
Trade Name: BILAXTEN
Pharmaceutical Form: Tablet
INN or Proposed INN: BILASTINA
CAS Number: 202189-78-4
Current Sponsor code: F-96221-BM1
Other descriptive name: BILASTINA
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) with an age between 18 and 40 years (both included). 2 Body weight within the normal range (BMI between18 and 30 kg/m2. 3 Medical history, physical examination by organs, both within normal limits. 4 No evidence of significant disease (organic or psychiatric) based on anamnesis taking, physical examination and complementary tests. 5 Laboratory tests (complete blood count and chemistry) within the normal ranges according to the normal reference values of the chemistry laboratory of the "Hospital de la Santa Creu i Sant Pau". Variations may be admitted in accordance with the CIM's clinical criterion. 6 Vital signs (systolic and diastolic blood pressure, heart rate and temperature) and ECG record within normal ranges. 7 Child-bearing potential female volunteers must use contraceptive measures other than hormonal contraceptives. 8 Induced wheal area values within the reference range of the Research Institute (55.21 mm2-259.41 mm2), in the histamine skin reaction test performed during the selection. 9 Free will to participate in the study, with written informed consent signed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=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. 2 Heavy consumer of stimulating drinks (>5 cups of coffee, tea, chocolate or cola drinks per day). 3 Background of alcoholism or drug dependence in the last one year or daily consumption of alcohol >40 gr/day for men or 24 gr/day for women. 4 Use of any medication within 2 weeks prior to taking the study treatment, (except for the use of paracetamol in short-term symptomatic treatments) including over-the-counter medications and medicinal plants. 5 Positive serology for hepatitis B, C or HIV. 6 Positive results for abuse drugs 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-galactosemalabsorption. 9 Smokers. 10 Pregnancy or lactation status. 11 To have participated in another clinical trial during the 3 months prior to study starts. 12 To have donated blood in the 4 weeks prior to study starts. 13 To have underground major surgery during the previous 6 months. 14 Positive dermographism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: TO COMPARE THE EFFICACY OF BILASTINE 20 MG, DESLORATADINE 5 MG AND RUPATADINE 10 MG IN THE REDUCTION OF HISTAMINE-INDUCED SKIN REACTIVITY IN HEALTHY VOLUNTEERS.;Secondary Objective: TO EVALUATE THE SUBJETIVE FEELING OF ITCHING AFTER HISTAMINE INOCULATION AND THE ONSET OF ACTION FOR EVERY TREATMENT VERSUS PLACEBO. TO EVALUATE THE TOLERABILITY AND SAFETY OF PRODUCTS.;Primary end point(s): The porcentage (%) of reduction of the wheal and flare areas obtained after study drug administrations in comparison to their corresponding baseline values in cm3. The following formula will be used: % reduction=[(postdose value - baseline value) x 100] / baseline value;Timepoint(s) of evaluation of this end point: From the administration of the treatment up to 24 hour after, each one of the formulations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Maximum inhibition time: time (h) in which the maximum wheal and flare inhibition is reached. Itching sensation: changes (mm) in the VAS respect to the corresponding baseline values. Onset of action: for every treatment versus placebo, defined as the first time point where the difference in wheal surface is statistically significant compared to placebo. Incidence of adverse events for each treatment. Changes in the tolerability parameters (laboratory tests, vital signs, ECG parameters) evaluated in terms of clinical relevance.;Timepoint(s) of evaluation of this end point: Maximal time inhibition and onset of action will be determinated during the measures of the skin reactivity in differents times described in the protocol, during each one of the formulations. Itching sensation will be evaluated in differents times described in the protocol, during each one of the formulations. Tolerability parameters: laboratory tests and ECG parameters will be evaluated during the inclusion phase and at the end of study; vital signs will be evaluated during the inclusion phase, baseline (premedication), +1 hour, +2 hours, +4 hours, +6 hours, +9 hours, +12 hours, y +24 hours post-doses, after each one of the formulations. Incidence of adverse event will be recorded during all the clinical trial. | — |
Countries
Spain
Contacts
Public ContactClinical Research Director
FAES FARMA, S.A.
Outcome results
None listed