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

• Status: Unknown status
• Trial end date: 2018-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Richever Enterprise Co., Ltd.
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

Subject must fulfill all of the following criteria to be eligible for the study:

1. Male or female with age between 20-85.

2. Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.

Exclusion Criteria:

Any of the following criteria will disqualify the subject from participation:

1. History of serious allergic reaction to galactose and have galactosemia.

2. History of receiving total gastrectomy, subtotal gastrectomy, celiac disease, or small intestinal resection.

3. History of diabetes mellitus.

4. Subjects are children or handicapped people.

5. Subjects with any other reasons considered by the investigator not in the condition to enter into the trial.