drugset / Trial / NCT03450772

Equivalence Study to Compare Two Strengths of Creon in China

NCT03450772

Phase 3 Unknown 60 enrolled Abbott
RandomizedCrossoverOpen-labelTreatment

Summary

This will be an open-label, randomized, multicenter, cross-over study in 60 subjects with PEI delivering data of 60 subjects for Pancreatin Enteric-Coated Capsules 25000 and of 60 subjects for Pancreatin Enteric-Coated Capsules 10000. The study will be conducted in up to 10 sites in China.

Timeline

Start
2017-08-31
Primary completion
2022-04
Completion
2022-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Pancrelipase Protein / enzyme biologic