Phase IV, single centre, randomised, open-label, two-period, two-way crossover clinical trial to assess the efficacy of Bilastine 20mg in the suppression of wheal and flare induced by intradermal histamine in healthy volunteers under fasted and fed conditions.

FAES FARMA, S.A.0 sites24 target enrollmentApril 9, 2018

ConditionsALLERGIC RHINOCONJUNTIVIS AND CHRONIC URTICARIA Therapeutic area: Diseases [C] - Immune System Diseases [C20]

DrugsBILAXTEN

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ALLERGIC RHINOCONJUNTIVIS AND CHRONIC URTICARIA
Sponsor: FAES FARMA, S.A.
Enrollment: 24
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 9, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

FAES FARMA, S.A.

Eligibility 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 \< 28\.0 kg/m2\) expressed as weight (kg) / height (m2\). 7 Subjects must be willing to use a medically acceptable barrier method of contraception throughout the study. Hormonal contraceptives and IUDs are not permitted. 8 Induced wheal area values within the reference range of the Research Institute \[0\.5521 cm2 – 2\.5941 cm2], in the histamine skin reaction test performed during the selection. 9 Free acceptance to participate in the study by means of a signed informed consent form approved by the Ethics Committee of the Hospital (CEIC).
•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

•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.