Tadalafil for erectile dysfunction Urological and Genital Diseases
Conditions
Interventions
For each subject, a single dose of IBSA tadalafil 20 mg orodispersible film under fed conditions, a single dose of IBSA tadalafil 20 mg orodispersible film under fasting conditions and a single dose o
Sponsors
IBSA Institut Biochimique (Switzerland)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and Age: men, 18-45 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 2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study; presence of mouth lesions or any other oral mucosa alteration; 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 (PDE5 inhibitors) or formulations' ingredients or both; 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, immunological 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 medications and herbal remedies for 2 weeks before the start of the study. Nitrates will not be allowed for 2 weeks 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 2020-2025], 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 tmax) and extent (AUC0-72h) of tadalafil absorption in plasma measured from plasma samples taken at pre-dose (0) and 20 min, 40 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 and 72 h post-dose after administration of IBSA tadalafil 20 mg orodispersible film and Cialis® 20 mg film-coated tablet under fed conditions | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate (Cmax and tmax) and extent (AUC0-72h) of tadalafil absorption in plasma measured from plasma samples taken at pre-dose (0) and 20 min, 40 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 and 72 h post-dose after administration of IBSA tadalafil 20 mg orodispersible film under fed and fasting conditions 2. Relative bioavailability (Frel), area under the concentration-time curve from administration to 8 h post-dose (AUC0-8h) and, if feasible, area under the concentration-time curve extrapolated to infinity (AUC0-inf) and elimination half-life (t1/2) of plasma tadalafil 3. All adverse events occurring after informed consent signature but before the first dose of the investigational medicinal product (PTAEs), all adverse events occurring or worsening after the first dose of the investigational medicinal product (TEAEs), vital signs (blood pressure and heart rate, measured at the screening visit, on Days 1-2 and 4 at pre-dose (0), 4, 5, 24 and 72 h post-dose of each study period and 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 and final visit/ETV as applicable). | — |
Countries
Switzerland
Outcome results
None listed