Vardenafil Nasal Spray in healthy volunteers including over 65's (15 days confinement in Sydney)

Vardenafil is a medication currently available in tablet form that is used to treat erectile dysfunction. This study is testing a new nasal spray version called SDS089, which is designed to work faster and at a lower dose than the tablet form. By delivering the drug through the nose rather than swallowing it, researchers expect the medication to enter the bloodstream more quickly and predictably. Healthy adult male volunteers will take part in a 15-day residential stay at a clinical trial unit in Sydney. In the first part of the study, each participant will receive three different treatments in random order — two doses of the nasal spray and the standard tablet — with rest days in between. In the second part, participants will take the nasal spray daily for five days. Blood levels of the drug will be carefully monitored throughout. You may be eligible if you are a healthy adult male aged 18 or older with a BMI between 18 and 32, no significant health conditions, and no current blood pressure medications. The study is particularly seeking to include men aged 65 and over as approximately half the participants. You must be willing to stay at the clinical trial unit for the full 15 days and abstain from alcohol, smoking, and caffeine during that time.