An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI)

Inclusion Criteria: * Subjects must have the ability to give informed consent * Female subjects must use a medically acceptable form of birth control and have a negative pregnancy test upon entering the study and not be breast-feeding * Subjects must have medical condition compatible with exocrine pancreatic insufficiency * Subjects must be off therapeutic doses of pancreatic enzyme supplementation prior to study entry day * Subjects must be on omeprazole at least 5 days prior Day 0. Exclusion Criteria: * Subjects with a known hypersensitivity and/or contraindication to VIOKASE®16 or to any non-active component of VIOKASE or to any protein of porcine origin * Subjects with a known hypersensitivity and/or contraindication to omeprazole or to any non-active component of omeprazole * Subjects on enzyme therapy, H2-receptor antagonists, anticholinergics, antispasmodics prior to study entry * Female subjects who are pregnant or lactating * Subjects with acute pancreatitis or acute exacerbations of chronic pancreatic disease * Subjects with a history of solid organ transplant or significant bowel resection between esophagus and pancreas * Subjects who have received an investigational new drug within 30 days prior to entry into the study. * Subjects with a known coagulopathy * Subjects with any abnormal liver function test * Subjects known to have a significant medical and/or mental disease that would compromise the subject's welfare or confound the study results * Subjects who are not on omeprazole at least 5 days prior Day 0