This will be an open-label, randomized, multicenter, cross-over study in 60 subjects with PEI delivering data of 60 subjects for Pancreatin Enteric-Coated Capsules 25000 and of 60 subjects for Pancreatin Enteric-Coated Capsules 10000. The study will be conducted in up to 10 sites in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Experimental drug
Active comparator
Shanghai Changhai Hospital
Shanghai, China
RECRUITINGCoefficient of fat absorption
Time frame: 5 days
fat intake - fat excretion/fat intake x 100
Time frame: 5 days
stool weight
Time frame: 5 days
Clinical symptomatology
stool frequency, stool consistency, abdominal pain, flatulence
Time frame: 5 days and 24 weeks
Subject's acceptance of treatment and preference
Subject's acceptance of treatment will be judged based on the following scale: very good, good, moderate and unsatisfactory. Which treatment did you prefer? No difference between treatment 1 and treatment 2 Treatment 1 is better than treatment 2 Treatment 2 is better than treatment 1
Time frame: 5 days and 24 weeks
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