ISRCTN79039906已完成1 期
Single dose crossover comparative bioavailability study of tadalafil 20 mg oral film and soft-gel capsule versus Cialis® (tadalafil) 20 mg tablet in healthy male volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
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. Male, at least 18 years of age but not older than 50 years
- •2. Non- or ex-smokers
- •3. Body mass index (BMI) within 18.5 to 30.0 kg/m2, inclusively
- •4. No clinically significant abnormality found in the 12-lead electrocardiogram (ECG) performed at study entry
- •5. Healthy according to medical history, complete physical examination (including vital signs and penis examination) and laboratory tests (general biochemistry including lipid profile, hematology and urinalysis)
排除标准
- •Volunteers presenting any of the following will not be included in the study:
- •1. Presence or history within 28 days of any tongue piercings
- •2. Presence of partials, braces or dentures
- •3. Seated pulse rate less than 50 Beats per Minute (bpm) or more than 100 bpm at screening
- •4. Seated blood pressure below 100/60 mmHg at screening
- •5. Seated blood pressure higher than 140/90 mmHg at screening and prior to 1st dosing
- •6. History of significant hypersensitivity to tadalafil or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- •7. Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- •8. History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
- •9. Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- •10. Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
- •11. Presence of out-of-range cardiac interval (PR < 110 msec, PR > 200 msec, QRS <60 msec, QRS >110 msec and QTc > 440 msec) on the screening ECG or other
- •clinically significant ECG abnormalities
- •12. Use of organic nitrate medication in the previous 28 days before day 1 of the study
- •13. Use of PDE 5 inhibitors (such as sildenafil) in the previous 28 days before day 1 of the study
- •14. Volunteer at increased risk of priapism, including subjects with sickle cell anemia, multiple, myeloma, leukemia, etc
- •15. Presence or history of non-arteritic anterior ischemic optic neuropathy (NAION)
- •16. Presence or history of anatomical deformation of the penis (i.e. angulation, cavernosal fibrosis or Peyronie’s disease)
- •17. Known presence of rare hereditary problems of galactose and /or lactose intolerance, lactase deficiency or glucose-galactose malabsorption
- •18. 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)
- •19. Any clinically significant illness in the previous 28 days before day 1 of this study
- •20. Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine,
- •erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates,
- •carbamazepine, glucocorticoids, phenytoin, rifampin and St John’s Wort), in the previous 28 days before day 1 of this study
- •21. Any history of tuberculosis and/or prophylaxis for tuberculosis
- •22. Positive screening of alcohol and/or drugs of abuse
- •23. Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests
- •24. Volunteers who took tadalafil in t
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