EC-high-buffered pancrelipase

Placebo

EC-high-buffered pancrelipase/Placebo ratio

Enzyme

ID

Cmax

Tmax

AUC

Cmax

Tmax

AUC

Cmax

AUC

 

 

USP Units/mL

min

USP Units*hr/mL

USP Units/mL

 

USP Units*hr/mL

min

 

Lipase

CF-

1562

15

2737

1629

135

2538

0.96

1.08

 

CF+

499

45

229

7.55

165

8.16

66.1

28.1

Amylase

CF-

735

90

1308

446

135

803

1.65

1.63

 

CF+

942

105

1470

59.3

45

62.4

15.9

23.5

Protease

CF-

919

90

1736

559

165

809

1.64

2.15

 

CF+

827

45

954

1.27

105

3.10

651

308


Ratios of peak enzyme concentration and AUCs, active treatment compared to placebo, are shown. Cmax-peak enzyme concentration; AUClast- area under the duodenal enzyme concentration vs. time curve through the last measurable time point, Tmax- time to Cmax.
Table 3: Comparison of duodenal enzyme concentrations.