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

NCT03457311 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-03-07

No results posted yet for this study

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.

Conditions

  • Galactose Single Point (GSP), Residual Liver Function

Interventions

DRUG

G.S.P. Oral Solution 400 mg/ml

Oral 1.25 ml/kg BW G.S.P. oral solution after fasting for 6 hours.

Sponsors & Collaborators

  • Richever Enterprise Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-09
Primary Completion
2018-03-31
Completion
2018-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03457311 on ClinicalTrials.gov