Futura Medical Developments Ltd (FMD) are developing a gel formulation of GTN (MED2005) as a
topical treatment for ED delivered using DermaSys®, a versatile and bespoke technology.
Treatment requires the application of a small quantity of gel (approx 300 mg), containing a
fixed dose of GTN, to the glans of the penis. Pharmacokinetic studies in healthy volunteers
indicate rapid absorption of the drug and low systemic exposure, reducing the risk of adverse
events (such as headache) commonly associated with GTN therapy.
The purpose of this study is to demonstrate similar or lower bioavailability of GTN from
MED2005 (test IMP) with that from Nitrostat (reference IMP).
The study will be conducted in two parts (Part 1 and 2). Part 1 will be conducted in 30
subjects and Part 2 will be conducted in 10 subjects. Part 1 will compose of a pre-study
screen, followed by six treatment periods and a post-study follow-up.
Part 2 will compose of a pre-study screen, followed by two treatment periods and a post-study
follow-up. Subjects can only participate in either Part 1 or 2 of the study (not both).