EPI due to Cystic Fibrosis?
Be a part of our solution.
Summary Locations

Summary

About this study

The purpose of the SOLUTION study is to evaluate the efficacy and safety of Sollpura™ capsules compared to approved, porcine-derived, enterically-coated and encapsulated pancreatic enzyme replacement therapy in patients with cystic fibrosis-related exocrine pancreatic insufficiency (EPI). The primary endpoint of the study will evaluate the non-inferiority of Sollpura™ compared with porcine pancreatic enzyme replacement therapy based on the change in the coefficient of fat absorption (CFA).



Lipase

Protease

Amylase

Sollpura™ is a biotechnology-derived, non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase, manufactured using modern biotech methods as a powder and packaged in a capsule. Sollpura™ is stable in stomach and digestive fluids allowing administration in a variety of convenient formulations without enteric coating.

Locations

Current locations that are recruiting