UnknownPhase 3

Clinical Study for Development of Oral Galactose Single Point (OGSP) Solution (G.S.P. Oral Solution®)

200 participantsStarted 2013-09-09

Plain-language summary

The primary objective is to determine the oral galactose single point (OGSP) cutoff values to discriminate subjects with different hepatic function. The secondary objective is to analyze the correlations between OGSP and other hepatic function assessment methods among this trial subjects.

Who can participate

Age range20 Years – 85 Years

SexALL

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Inclusion criteria

✓. Male or female with age between 20-85.
✓. Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.

Exclusion criteria

✕. History of serious allergic reaction to galactose and have galactosemia.
✕. History of receiving total gastrectomy, subtotal gastrectomy, celiac disease, or small intestinal resection.
✕. History of diabetes mellitus.
✕. Subjects are children or handicapped people.
✕. Subjects with any other reasons considered by the investigator not in the condition to enter into the trial.

What they're measuring

Blood concentration of oral galactose

Timeframe: Sixty minutes

Trial details

NCT IDNCT03457311

SponsorRichever Enterprise Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-03-31

View on ClinicalTrials.gov More Galactose Single Point (GSP), Residual Liver Function trials