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 个研究点目标入组 24 人开始时间: 2018年4月9日最近更新: 2018年9月17日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: FAES FARMA, S.A.
入组人数: 24

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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

排除标准

•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.

研究者

发起方

FAES FARMA, S.A.

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