Erectile dysfunction Urological and Genital Diseases Erectile dysfunction
Conditions
Interventions
Three treatments are administered as a single 100 mg oral dose. Each of the 45 healthy male subjects receives in each period one of the following treatments, according to a randomized, 3-period, cross
Sponsors
IBSA Institut Biochimique S.A.
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters (Cmax, AUC, Tmax, Thalf, ?Z) for the absorption of sildenafil. The concentration of sildenafil in plasma is measured at the following time-points: pre-dose (0) and 10, 15, 20, 30, 40, 50 min, 1 h, 1:20, 1:40, 2, 2:20, 2:40, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after the dose in each of the three study periods. Each study period is separated by at least 7 calendar days. Plasma samples are assayed for sildenafil using a validated high performance liquid chromatography (HPLC) method with tandem mass spectrometry (MS/MS) detection. The lower limit of quantitation (LOQ) and upper limit of quantitation (ULQ) are 1.00 and 1000.00 ng/ml for sildenafil. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Record of adverse events throughout the study. Any new illness, or worsening of a concomitant illness, and the medically relevant abnormalities in laboratory tests, physical examination and in the measurements of vital signs performed after drug administration or at the end of the study are to be recorded as adverse events. The period of observation of adverse events extends from the pre-trial evaluation until the collection of the last blood sample of the study. During the study, all adverse events spontaneously reported by the subject, observed by the clinical staff, or elicited by general questioning are recorded at any time. Subjects are questioned on their health status at the beginning of each study period and before each departure from the clinical site. 2. Vital signs: Blood pressure, pulse rate and body temperature are measured and recorded prior to each drug administration. Blood pressure and pulse rate are also recorded approximately 1, 2 and 4.5 hours after each drug administration. 3. Physical examination, performed at screening and at final visit after the last study period. 4. Laboratory analysis: haematology, blood chemistry and urinalysis laboratory tests performed at screening and at final visit after the last study period. | — |
Countries
Canada
Outcome results
None listed