A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age
Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
A study to determine the safety, effectiveness, and acceptability of 2 methods of
administration of EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) 3,000
lipase units capsule, a pancreatic enzyme product (PEP), in infants with exocrine pancreatic
insufficiency (EPI) due to cystic fibrosis (CF). This study is sponsored by Aptalis Pharma
(formerly Eurand).