Karessa Pharma Holding AB announces today that they have been approved by the MPA to start a clinical study with K-03 Vardenafil buccal film
Karessa submitted an application to the Swedish Medical Products Agency on 31st of August to perform a Phase I study on healthy volunteers of male subjects. Today, the Medical Products Agency announced that they approved the application.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