Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum)

Exclusion Criteria

• •History of fibrosing colonopathy in CF subjects
• •Current diagnosis or a history of distal intestinal obstruction syndrome (DIOS) in the past 4 months
• •Known contraindication, sensitivity or hypersensitivity to porcine pancreatic enzymes
• •Active liver disease
• •ALT or AST \>3 times the upper limit of normal
• •Bilirubin \>3 times the upper limit of normal
• •Acute pancreatitis or acute exacerbation of chronic pancreatitis
• •Acute treatment with any systemic (oral or IV) antibiotics two weeks prior to screening
• •Subjects on erythromycin unwilling to discontinue the treatment two weeks prior to screening
• •Receiving treatment with antacids or H2 receptor blockers or proton pump inhibitors and unable to discontinue these treatments prior to day 1
• •Inability to cooperate with or non-compliant with required study procedures
• •Pregnant, breast feeding
• •Current daily prescribed scheduled use of narcotics (patients requiring PRN use of narcotics are not excluded)
• •Poorly controlled diabetes
• •A medical condition which the investigator deems significant enough to interfere with the ability of the subject to participate in the intubation study or interfering with assessment or enzyme bioavailability
• •Stomach pH \> 4
• •Small bowel disease (i.e. celiac disease)