A single-centre, randomized, double-blind, crossover, single-dose clinical trial to compare bilastine, desloratadine, rupatadine and placebo in the suppression of wheal and flare induced by intradermal histamine in healthy volunteers.

FAES FARMA, S.A.0 个研究点开始时间: 2015年5月8日最近更新: 2015年10月12日

适应症

试验速览

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•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

•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.

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