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 sitesMay 8, 2015

Overview

No summary available.

Registry

who.int

Start Date

May 8, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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.