Erectile dysfunction Mental and Behavioural Disorders
Conditions
Interventions
A single dose of the investigational medicinal product (Sildenafil IBSA 100 mg oral film) without water, a single dose of the investigational medicinal product with water and a single dose of Viagra®
Sponsors
IBSA Institut Biochimique (Switzerland)
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and Age: males, 18-55 years old inclusive 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: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study.
Exclusion criteria
Exclusion criteria: 1. Electrocardiogram (12-lead ECG in supine position): clinically significant abnormalities; out of range intervals (PR 200 msec, QRS 110 msec and QTc > 440 msec) 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; presence of any partials, braces or dentures 3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness 4. Allergy: ascertained or presumptive hypersensitivity to the active principle 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, haematological, 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 (OTC) medications and herbal remedies for 2 weeks before the start of the study. Organic nitrates will not be allowed for 28 days before screening 7. 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 8. Blood donation: blood donations for 3 months before this study 9. 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) 10. Drug test: positive result at the drug test at screening or day-1 11. Alcohol test: positive alcohol breath test at day -1 12. Diet: abnormal diets (3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate (Cmax) and extent (AUC0-t and AUC0-inf, if feasible) of sildenafil absorption in plasma measured from plasma samples taken at pre-dose (0) and 6, 15, 30, 45 min and 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to peak (tmax), relative bioavailability (Frel) and, if feasible, elimination half-life (t1/2) and terminal elimination rate constant (?z) of plasma sildenafil measured from plasma samples taken at pre-dose (0) and 6, 15, 30, 45 min and 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h post-dose 2. Rate (Cmax) and extent (AUC0-t and AUC0-inf if feasible) of absorption, time to peak (tmax), relative bioavailability (Frel) and, if feasible, elimination half-life (t1/2) and terminal elimination rate constant (?z) of plasma N-desmethyl-sildenafil measured from plasma samples taken at pre-dose (0) and 6, 15, 30, 45 min and 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h post-dose 3. All adverse events occurring or worsening after the informed consent signature before (PTAEs) and after (TEAEs) the first dose of investigational medicinal product, vital signs (blood pressure and heart rate, measured at screening visit, in each study period at pre-dose (0), 1.5 and 24 h post-dose, at early termination visit [ETV] if applicable), body weight (measured at screening and final visit/ETV as applicable), physical examinations (performed at screening and final visit/ETV as applicable), clinical laboratory parameters (haematology, blood chemistry and urine analysis performed at screening and final visit/ETV as applicable; virology performed at screening visit; urine drug test performed at screening and at the entrance of each study period), ECG (performed at screening, in each study period at 24 h post-dose, at ETV, if applicable). | — |
Countries
Switzerland
Outcome results
None listed