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

• Documented chronic pancreatitis, alcohol induced chronic pancreatitis or cystic fibrosis
• Documented pancreatic enzyme insufficiency as determined by spot fecal elastase-1 \<75 mcg/g stool at the time of inclusion in the study
• Required daily exogenous enzyme supplementation with commercially available pancreatic enzymes
• > 18 years of age
• Male and female subjects qualify
• Able to swallow capsules
• Clinically stable with no evidence of an acute medical condition
• History of steatorrhea

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)