A phase I study to assess the effect of three single ascending doses of sildenafil citrate oral film compared with placebo on blood pressure in healthy young and elderly male volunteers

IBSA Institut Biochimique (Switzerland)0 个研究点目标入组 26 人2022年11月28日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: IBSA Institut Biochimique (Switzerland)
入组人数: 26
状态: 已完成
最后更新: 3年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2022年11月28日

结束日期

2021年12月1日

最后更新

3年前

研究类型

Interventional

性别

Male

研究者

发起方

IBSA Institut Biochimique (Switzerland)

入排标准

入选标准

•1\. Informed consent: signed written informed consent before inclusion in the study
•2\. Sex and Age: males, 18\-45 inclusive (young) versus \=65 (elderly) years old
•3\. Body Mass Index: 18\.5\-30 kg/m2 inclusive
•4\. Vital signs: systolic blood pressure 100\-139 mmHg, diastolic blood pressure 50\-89 mmHg, heart rate 50\-90 bpm, measured after 5 min at rest in the sitting position
•5\. Full comprehension: the ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the Investigator and to comply with the requirements of the entire study

排除标准

•1\. Electrocardiogram (12\-lead ECG in supine position): clinically significant abnormalities
•2\. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study; presence or history (within 28 days) of any tongue piercings
•3\. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
•4\. Allergy: ascertained or presumptive hypersensitivity to the active principle (PDE5 inhibitors) and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
•5\. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine or neurological diseases that may interfere with the aim of the study; history of vision or hearing problems related to drugs of the PDE5 inhibitor pharmacological class; history of priapism; anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease); history of ophthalmologic diseases like non\-arteritic anterior ischemic optic neuropathy or retinitis pigmentosa
•6\. Medications: medications, including over\-the\-counter medications and herbal remedies for 2 weeks before the screening visit
•7\. Nitrates: treatment with nitrates for 2 weeks before the screening visit
•8\. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3\-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
•9\. Blood donation: blood donations for 3 months before this study
•10\. Drug, alcohol, caffeine, tobacco: history of drug, alcohol \[\>2 drinks/day, defined according to the USDA Dietary Guidelines 2015\-2020], caffeine (\>5 cups coffee/tea/day) or tobacco abuse (?10 cigarettes/day)

结局指标

主要结局

未指定

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