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Equivalence Study to Compare Two Strengths of Creon in China

NCT03450772 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-11-24

No results posted yet for this study

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.

Conditions

  • Pancreatic Insufficiency

Interventions

DRUG

Creon® 25000

Experimental drug

DRUG

Creon® 10000

Active comparator

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03450772 on ClinicalTrials.gov