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| Figure 3: Duodenal enzyme concentrations and pH values in subject CF+. In Phase 1 (placebo+meal), the concentration of lipase and protease in the duodenal fluid were negligible, and there was a small amylase peak 45 min post-dose. The pH was 6.5 at onset, and increased to a maximum of 8.0 and then fell to a value of 7.0 due to the bicarbonate buffer content of the Placebo formulation. After administering pancreatic enzymes in Phase 2 (EC high-buffered pancrelipase+meal), lipase concentrations peaked at 45 min postdose. Two peaks were observed for amylase and protease at 45 and 105 minutes postdose. The pH increased from 6.5 at baseline to 8.0 at the first peak release of enzymes. Given the negligible background enzyme concentrations, this suggested both release of pancreatic enzymes as well as the bicarbonate buffer from the formulation in Phase 2. Arrows indicate time when all meal and study drug had been ingested and sample collection was started. Baseline concentrations are plotted at 240 min for Phase 2. |
