24
Participants
Start Date
November 26, 2018
Primary Completion Date
March 5, 2019
Study Completion Date
March 8, 2019
Lactulose crystals 20 g
White or almost white crystalline powder. The product will be provided in sachets to be dissolved in 250 mL water.
Lactulose crystals 30 g
White or almost white crystalline powder. The products will be provided in sachets to be dissolved in 250 mL water.
Lactulose liquid 20 g
Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
Lactulose liquid 30 g
Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
Glucose
White crystalline powder. To standardise for 30 g glucose, 33 g glucose monohydrate will be used. The products will be provided in sachets to be dissolved in 250 mL water.
Still water
250 mL still water will be used. Water from the same source will be also used to dissolve investigational and control products
Clinical Research Center (CRC), Graz
Lead Sponsor
Fresenius Kabi
INDUSTRY