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Loperamide Grapefruit Juice Interaction PK Trial

NCT00806299 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2011-10-06

No results posted yet for this study

Summary

A 10-day study to determine if grapefruit juice has any effect on how loperamide (Imodium) affects the body and how the body affects loperamide.

Conditions

  • Drug Interaction

Interventions

DRUG

Loperamide / Red Grapefruit Juice

Fixed sequence of loperamide 4 mg with and without red grapefruit juice

DRUG

Loperamide/ White Grapefruit Juice

Fixed sequence of loperamide 4 mg with and without white grapefruit juice

DRUG

Loperamide / Pink Grapefruit Juice

Fixed sequence of loperamide 4 mg with and without pink grapefruit juice

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    lead INDUSTRY

Principal Investigators

  • Dolly Parasrampuria, PhD · McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2008-11-30
Completion
2008-11-30

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 NCT00806299 on ClinicalTrials.gov