Equivalence Study to Compare Two Strengths of Creon in China

Inclusion Criteria:

• Signed informed consent
• Subjects ≥ 18 years
• A) Chronic pancreatitis must be documented in the medical file by at least one of thefollowing methods:
• Imaging techniques (ultrasound, CT, MRI, or endoscopic ultrasound)
• ERCP (endoscopic retrograde cholangiopancreatography)
• Plain film of the abdomen with pancreatic calcification or
• B) Partial or total pancreatectomy ≥ 30 days prior to enrollment and without currentpostsurgery complications
• PEI proven by human fecal elastase ≤ 100 µg/g stool (during the screening period)
• Subjects without Creon (Pancreatin Enteric Coated Minimicrospheres) intake in the pastthree months
• Females of child-bearing potential should agree to continue using a medicallyacceptable method of birth control throughout the study and for 30 days immediatelyafter the last dose of study drug. Medically acceptable methods of birth controlinclude bilateral tubal ligation or the use of either a contraceptive implant, acontraceptive injection (e.g. Depo-Provera™), an intrauterine device, or an oralcontraceptive taken within the past three months where the subject agrees to continueusing during the study or to adopt another birth control method, or a double-barriermethod which consists of a combination of any two of the following: diaphragm,cervical cap, condom, or spermicide

Exclusion Criteria:

• Subjects with a history of fibrosing colonopathy
• Solid organ transplant
• Surgery affecting the stomach or bowel, except pancreatectomy or appendectomy
• Surgery affecting the stomach or bowel, except pancreatectomy or appendectomy
• Subjects with recurrent malignant tumors of any kind
• Use of an immunosuppressive drug or chemotherapy
• Acute phase of pancreatitis
• Acute phase of pancreatitis
• Subjects who are not able or willing to ingest 90g fat/day (± 10 g fat/day) during thecross-over periods or are not willing to collect complete stools during thedemarcation period.
• Subjects in an instable condition after pancreatic surgery (Karnofsky index < 70)
• Known infection with HIV
• Pregnancy or lactation
• Current excessive alcohol intake or drug abuse
• Investigational drug intake within prior 30 days
• Known allergy against pancreatin of porcine origin or to any of the excipients ofPancreatin Enteric-Coated Capsules
• Suspected non-compliance or non-cooperation
• Celiac disease, Crohn´s disease
• Ileus or acute abdomen in the medical history
• Mental disability or any other lack of fitness, in the investigator's opinion, topreclude subject's participation in or to complete the study
• Any acute or chronic disease (i.e infectious diseases) which may limit thehospitalization, dietary adherence or stool collection or completion of the studyprocedures