A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocr

• Status: Recruiting
• Trial end date: 2022-11-15

Summary

Part 1 is a study to demonstrate that pancrelipase Delayed Release (DR) capsules manufactured with a Modernized Process (MP) is non-inferior to currently marketed pancrelipase DR capsules in participants with EPI due to Cystic Fibrosis (CF), as measured by Coefficient of Fat Absorption (CFA). Safety will also be evaluated. Part 2 is a study to demonstrate that pancrelipase manufactured with an Alternate Active Pharamceutical Ingredient Site (AAPIS) is non-inferior to currently marketed active control (Creon®) in participants with EPI due to Cystic Fibrosis (CF), as measured by Coefficient of Fat Absorption (CFA).

• Phase: Phase 4

Details

• Lead Sponsor: AbbVie
• Treatments: Pancreatin; Pancrelipase