drugset / Trial / NCT03450772
Equivalence Study to Compare Two Strengths of Creon in China
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pancrelipase | Protein / enzyme biologic | — | — |