ISRCTN13297409已完成1 期
Single Dose Crossover Comparative Bioavailability Study under Fasting Conditions and Food Effect Study of Sildenafil 100 mg Oral Films Versus Viagra® (Sildenafil) Tablets in Healthy Male Volunteers
IBSA Institut Biochimique S.A.0 个研究点目标入组 45 人开始时间: 2018年9月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Aged 18-45 years
- •2. BMI of 18.5 - 30.0 kg/m²
- •3. Non-smoker or ex-smoker
- •4. No clinically significant diseases or findings upon physical examination and/or clinical laboratory evaluations (hematology, general biochemistry, lipid profile, ECG and urinalysis)
- •5. Provided signed informed consent
排除标准
- •1. Presence or history within 28 days of any tongue piercings
- •2. Presence of partials, braces or dentures
- •3. History of significant hypersensitivity to sildenafil or related products (including excipients of formulations)
- •4. History of severe hypersensitivity reactions to any drugs
- •5. Significant gastrointestinal, liver or kidney disease, or any other conditions known to:
- •5.1. Interfere with the absorption, distribution, metabolism or excretion of drugs
- •5.2. Potentiate or predispose to undesired effects such as severe liver failure, acute or chronic liver dysfunction or cholestatic jaundice
- •6. History of significant gastrointestinal, liver or kidney disease that may have affected drug bioavailability
- •7. Significant cardiovascular, pulmonary, hematological, neurological, psychiatric, endocrine, immunological or dermatological disease
- •8. Suicidal tendencies, severe depression, state of confusion or other clinically relevant psychiatric diseases
- •9. History of or disposition to seizures
- •10. Presence of out-of-range cardiac interval on the screening ECG or other clinically significant ECG abnormalities
- •11. Use of organic nitrate medications in the previous 28 days
- •12. History of vision or hearing problems related to the PDE5 inhibitor pharmacological class
- •13. Presence or history of priapism
- •14. Anatomical deformation of the penis
- •15. History of ophthalmological disease, such as non-arteritic anterior ischemic optic neuropathy or retinitis pigmentosa
- •16. Known presence of rare hereditary problems of:
- •16.1. Galactose and/or lactose intolerance
- •16.2. Lactase deficiency
- •16.3. Glucose-galactose malabsorption
- •17. Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol (acute or chronic))
- •18. Positive screening for alcohol and/or drug abuse
- •19. Use of enzyme modifying drugs in the previous 28 days, including:
- •19.1. Strong inhibitors of CYP enzymes (e.g. cimetidine, fluoextine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals)
- •19.2. Strong inducers of CYP enzymes (e.g. barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St Johns Wort)
- •20. History of tuberculosis and/or prophylaxis for tuberculosis
- •21. Positive results to the following tests:
- •21.1. HIV Ag/Ab Combo
- •21.2. Hepatitis B surface antigen (HBsAG (B) (hepatitis B))
- •21.3. Hepatitis C Virus (HCV (C))
- •22. Taken sildenafil in the previous 28 days
- •23. Donated 500 ml or more of blood in the previous 56 days
研究者
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