4-O-β-D-galactopyranosyl-D-glucitol

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:

direct observations: clinical cases, poisoning incidents and other

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Absorption and Effect on Blood Lactate in Healthy Volunteers and Patients with Cirrhosis.

Author:

Metzger J, Chollet C, Wermeille M, Biollaz J, Llull JB, and Lauterburg BH

Year:

1988

Bibliographic source:

Eur. J. Clin. Pharmacol., 35(1):97-99

Materials and methods

Study type:

study with volunteers

Endpoint addressed:

basic toxicokinetics

Principles of method if other than guideline:

The gastrointestinal absorption of the test substance was studied in 6 healthy volunteers and 8 patients with cirrhosis.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-O-β-D-galactopyranosyl-D-glucitol

EC Number:

209-566-5

EC Name:

4-O-β-D-galactopyranosyl-D-glucitol

Cas Number:

585-86-4

Molecular formula:

C12H24O11

IUPAC Name:

4-O-beta-D-galactopyranosyl-D-glucitol

Method

Type of population:

other: healthy volunteers and patients with cirrhosis

Subjects:

Healthy volunteers: 5 male and 1 female
Patients with cirrhosis: 8 male (5 alcoholic and 3 chronic hepatitis B)

Ethical approval:

not specified

Route of exposure:

oral

Reason of exposure:

intentional

Details on exposure:

Patients ingested lactitol (0.5 g/kg) dissolved in warm water. No additional intake of fluids or food was permitted for the subsequent 4 hours. Blood and urine samples were obtained.

Results and discussion

Outcome of incidence:

The test substance was poorly absorbed from the gastrointestinal tract in healthy volunteers and patients with cirrhosis, and that the disaccharide did not disturb glucose or lactate homeostasis.

Applicant's summary and conclusion

Conclusions:

Following administration of the test substance, it was determined that the test substance was poorly absorbed from the gastrointestinal tract in healthy volunteers and patients with cirrhosis, and that the
disaccharide did not disturb glucose or lactate homeostasis.

Executive summary:

The gastrointestinal absorption of lactitol was studied in 6 healthy volunteers and 8 patients with cirrhosis. Following administration of lactitol (0.5 g/kg), no lactitol was found in serum. The urinary excretion of lactitol over 24 hours ranged from 0.1 to 1.4% of the administered dose (0.46% in cirrhotics and 0.35% in healthy volunteers). Blood D- and L-lactate and plasma glucose did not increase following lactitol. The data indicated that lactitol was poorly absorbed from the gastrointestinal tract in healthy volunteers and patients with cirrhosis, and that the disaccharide did not disturb glucose or lactate homeostasis.