Pilot bioavailability study of sildenafil 50 mg orodispersible film administered by the supralingual and the sublingual route to healthy men

IBSA Institut Biochimique (Switzerland)0 个研究点目标入组 12 人开始时间: 2020年11月25日最近更新: 2020年12月7日

适应症

试验速览

•1. Signed written informed consent before inclusion in the study
•2. Male participants aged between 18-45 years inclusive
•3. Body Mass Index (BMI) between 18.5-30 kg/m² inclusive
•4. Systolic blood pressure between 100-139 mmHg, diastolic blood pressure between 50-89 mmHg, heart rate between 50-90 bpm (all measured after 5 min at rest in the sitting position)
•5. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects, to co-operate with the investigator, and to comply with the requirements of the entire study

•1. Clinically significant abnormalities on electrocardiogram (12-lead ECG in supine position)
•2. Clinically significant abnormal physical findings which could interfere with the objectives of the study
•3. Clinically significant abnormal laboratory values indicative of physical illness
•4. Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients, or history of anaphylaxis to drugs or allergic reactions in general, which the investigator considered could affect the outcome of the study
•5. Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could 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); or history of ophthalmologic diseases like non-arteritic anterior ischemic optic neuropathy or retinitis pigmentosa

发起方

IBSA Institut Biochimique (Switzerland)