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RP-G28 administered in the fasted state for Lactose Intolerance (RP Trial)

Phase 1
Waitlist Available
Research Sponsored by Ritter Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2, 3, 2 and 1 days pretreatment; 1 - 13 days post-treatment
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Lactose Intolerance

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2, 3, 2 and 1 days pretreatment; 1 - 13 days post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2, 3, 2 and 1 days pretreatment; 1 - 13 days post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area under the plasma concentration-time curve from time 0 extrapolated to infinity
Secondary study objectives
Adverse events
Hematology
Serum chemistry
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: RP-G28 administered in the fed stateExperimental Treatment1 Intervention
RP-G28, 15 g dissolved in water, administered immediately following the consumption of a standard non-dairy meal
Group II: RP-G28 administered in the fasted stateExperimental Treatment1 Intervention
RP-G28, 15 g dissolved in water, administered in the fasted state
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RP-G28
2018
Completed Phase 3
~950

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ritter Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
995 Total Patients Enrolled
3 Trials studying Lactose Intolerance
995 Patients Enrolled for Lactose Intolerance
Paul G Pearson, PhDStudy DirectorRitter Pharmaceuticals
~2 spots leftby Nov 2025
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