2024-516569-35-00招募中4 期
A single-centre, randomized, double blind, placebo controlled, crossover, single dose clinical trial to compare orodispersible presentations of bilastine, ebastine, and desloratadine in the suppression of wheal and flare induced by intradermal histamine in healthy volunteers.
Faes Farma S.A., A. Menarini Industrie Farmaceutiche Riunite S.r.l.1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年4月10日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Onset of action: defined as the first time point (h) in which active treatments show a statistically significant difference in the inhibition of wheal and flare surface areas in comparison to that induced by placebo
研究概览
简要总结
The primary objective of this study is to determine the onset of action of the peripheral antihistaminic activity of bilastine 20 mg orodispersible tablet, ebastine 10 mg oral lyophilized, and desloratadine 5 mg orodispersible tablet versus placebo orodispersible tablet
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Free acceptance to participate in the study by obtaining signed informed consent form, approved by the hospital’s IEC.
- •Be willing to avoid excessive sun exposure or any procedure that could modify the colour of the skin.
- •Subjects of either sex (male or female) aged ≥ 18 and ≤ 50 years at the time of the enrolment.
- •Subjects not affected by any organic or psychic conditions.
- •No evidence of clinically significant abnormalities in medical records and physical examination, at screening.
- •No clinically significant abnormalities in haematology, biochemistry, or serology (hepatitis B surface antigen - HBsAg, hepatitis C antibodies – HCV Ab, or human immunodeficiency virus antibodies - HIV) assessments, at screening.
- •Vital signs (blood pressure, body temperature and heart rate) and electrocardiogram (ECG) record within normal range, at screening.
- •Body mass index within the range (BMI ≥ 18.5 and ≤ 30.0 kg/m2) expressed as weight (kg) / height (m2).
- •Women of childbearing potential must be willing to use a medically acceptable barrier method of contraception throughout the study and one week after the last IMP intake. Hormonal contraceptives and intrauterine hormone-releasing system (IUS) are not permitted.
- •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.
排除标准
- •Background of allergy, idiosyncrasy or hypersensitivity to the IMP or any related products (including excipients of the formulations).
- •Females with positive results from the pregnancy test, breast-feeding or planning a pregnancy.
- •Smoking within 6 months prior to the study treatment phase. Smokers must refrain from any tobacco usage, including smokeless tobacco, nicotine patches, electronic cigarettes, etc. at least for 6 months prior to study treatment phase).
- •Have participated in another clinical trial during the 3 months prior to study start (screening visit) in which an investigational drug, medical device or a commercially available drug was tested.
- •Have donated blood within the 4 weeks period before the screening visit.
- •Having undergone major surgery during the previous 6 months before screening visit, or have an intervention programmed during the study.
- •Mentally or legally incapacitated at screening.
- •Unwillingness or inability to follow the procedures outlined in the protocol.
- •Any condition that, in the opinion of the investigator, may jeopardise the subject’s well-being or the trial conduct according to the protocol.
- •Heavy consumer of stimulating drinks (> 5 cups of coffee, tea, chocolate, or cola drinks per day).
- •History of alcohol dependence or drug abuse in the last 5 years, or daily alcohol consumption > 40 g/day for men or > 24 g/day for women.
- •Intake of any medication within 14 days prior to taking the IMP (except for use of paracetamol in short-term symptomatic treatments, according to the investigator’s criteria, and specified contraceptives), or intake of over-the-counter products (including natural food supplements, vitamins and medicinal plant products) within 7 days prior to taking the IMP.
- •Positive HBsAg, HCV Ab or HIV results.
- •Positive results for abuse drugs in urine test or ethanol in breath test.
- •History or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, haematological, neurological disease or other chronic diseases.
- •Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •Positive dermographism.
结局指标
主要结局
Onset of action: defined as the first time point (h) in which active treatments show a statistically significant difference in the inhibition of wheal and flare surface areas in comparison to that induced by placebo
Onset of action: defined as the first time point (h) in which active treatments show a statistically significant difference in the inhibition of wheal and flare surface areas in comparison to that induced by placebo
次要结局
- Percentage of reduction vs placebo: % of reduction of wheal and flare surface areas obtained in each time point after studies drugs administration versus placebo.
- Percentage of reduction vs baseline: % of reduction of wheal and flare surface areas obtained in each time point after studies drugs administration, in comparison to their corresponding baseline value expressed in cm2
- Maximum effect: maximum percentage of reduction of wheal and flare surface areas
- Maximum effect time: time point (h) in which the maximum percentage of reduction of wheal and flare surface areas is reached
- Duration of effect: last time point (h) where wheal and surface areas show statistically significant differences, compared to placebo and versus baseline
- Subjective itching assessment: Mean change versus baseline on subjective itching sensation (VAS).
- Tolerability: Changes in the tolerability parameters (clinical laboratory tests, vital signs recording, ECG parameters) evaluated in terms of clinical relevance.
- Safety: Incidence of adverse events.
- Pharmacokinetic parameters: Drug plasma concentration and pharmacokinetic parameters (AUC0t, AUC0∞, Cmax, tmax, t1/2, Kel, Cl, Vd) calculated from those plasma levels.
研究者
Rosa Mª Antonijoan
Scientific
Faes Farma S.A.
研究点 (1)
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