A Study to Evaluate the Mode of Administration in Infants Less Than 12 Months of EUR-1008

• Effects of treatment on the oral mucosa [ Time Frame: up to 30 days ] [ Designated as safety issue: Yes ]
  Safety assessed by the presence of lesions observed during a physical exams at each visit. Severity of lesions measured by investigator's assessment using the following scale: Mild = asymptomatic or mild symptoms; intervention not indicated; Moderate = moderate pain; not interfering with oral intake, modified diet indicated; Severe = severe pain, interfering with oral intake and life threatening or fatal.
• Changes in clinical laboratory results [ Time Frame: up to 30 days ] [ Designated as safety issue: Yes ]
  Safety evaluated by treatment differences in results collected from standard of care laboratory assessments.
• Presence of the signs and symptoms of Exocrine Pancreatic Insufficiency (EPI) [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
  Efficiacy mesured by the treatment differences in clinical signs and symptoms of Exocrine Pancreatic Insufficiency (EPI. This will be done based upon reported diary entries of signs and symptoms of EPI. Specifically measuring stool consistency(soft to hard), Presence of blood, oil or grease in the stool, and abdominal pain, bloating and gas measured on a scale of 0 to 3.

A Study to determine the safety, effectiveness, and acceptability of 2 methods of administration of EUR-1008 3,000 lipase units capsules (the "EUR-1008"), a Pancreatic Enzyme Product ("PEP"), in infants with CF who need to take PEP medications to help break down the food that they eat.

Multicenter, randomized, open-label, crossover study in pediatric subjects with EPI associated with CF. The study will be carried out in infants between 1 and 12 months of age.

The study is comprised of 1 screening period followed by 2 treatment periods and a follow-up visit. During the Screening Period, all subjects will be administered ZENPEP®. Once determined eligible for participation, subjects will be randomized to 1 of 2 treatment groups, and administered treatment with 1 of 2 different methods of administration.

Inclusion Criteria:

• Diagnosis of CF
• Have the need for a PEP
• Willing to switch subject from their previous PEP(if any) to ZENPEP®
• Have a height to weight ratio target at greater than 10th percentile
• Clinically stable

Exclusion Criteria:

• Age <1 month and > 12 months
• History of meconium ileus or small bowel atresia that required surgery
• Allergic to pork or other porcines PEPs
• Respiratory condition that required an intervention
• Acute respiratory infection in the previous 14 days requiring antibiotics
• Change in antacid dose in the 7 days before screening
• Administration of oral, IM, IV glucocorticoids in the 4 weeks prior to screening
• Any condition that would, in the investigator's opinion, limit the subject's ability to complete the study
• Currently participating in or has participated in an investigational study, with the exception of observational studies, within 30 days of the screening visit.