Conditions: Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Keywords: maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 41
Healthy volunteers: no

Brief summary:
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis

Detailed description:

Arms:
arm 1: Subjects first received Creon N for 5 days. After a washout period of 3 to 14 days, they received Creon® for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to \<10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units. arm 2: Subjects first received Creon® for 5 days. After a washout period of 3 to 14 days, they received Creon N for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to \<10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.

Interventions: intervention 1: Creon® intervention 2: Creon N
Intervention descriptions: intervention 1: active comparator intervention 2: experimental drug

Protocol document: