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Effect of a Standard Meal on the Pharmacokinetic Profile of RP-G28 in Healthy Adult Male and Female Subjects

NCT03563846 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-08-08

No results posted yet for this study

Summary

Randomized, open-label, 2-period, 2-sequence, crossover study to evaluate the effect of a standard meal on the pharmacokinetic (PK) profile of orally administered RP-G28.

Conditions

  • Lactose Intolerance

Interventions

DRUG

RP-G28

RP-G28 is a purified galacto-oligosaccharide (GOS) product

Sponsors & Collaborators

  • Ritter Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul G Pearson, PhD · Ritter Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-09
Primary Completion
2018-04-13
Completion
2018-04-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03563846 on ClinicalTrials.gov