Karessa has today submitted an application for clinical trial for project K-03 to the Medical Products Agency
Karessa Pharma Holdning AB announces today that an application for a clinical trial with Vardenafil within the project K-03 has been submitted to the Swedish Medical Products Agency.The study is a Phase I, open, randomized, single-center study on healthy male subjects in order to determine the PK profile in the body (pharmacokinetic profile) of Vardenafil given as K-03/1 buccal film. The study consists of comparing the PK profile of four different variants of K-03/1 buccal film. Except for the evaluating of PK profile, the safety and tolerability of Karessa's K-03/1 buccal film will also be