Status:
COMPLETED
Loperamide Grapefruit Juice Interaction PK Trial
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Drug Interaction
Eligibility:
All Genders
18-59 years
Phase:
PHASE1
Brief 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.
Detailed Description
An open-label, randomized, single-dose, fixed-sequence crossover drug interaction study of loperamide HCl with grapefruit juice. About 33 healthy subjects, about equal numbers of men and women, 18 thr...
Eligibility Criteria
Inclusion
- Healthy male and/or female subjects between the ages of 18 and 59 years, inclusive
- No clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, and clinical laboratory tests.
- Subjects will have a Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs).
- Are normotensive with sitting blood pressure between the range of 90 - 140 mm Hg systolic and 50 - 90 mm Hg diastolic.
- Have a heart rate of 50-100 beats per minute (bpm).
- Have a negative urine drug screen at screening and at check-in to the research unit.
- If female of child-bearing potential, a negative pregnancy test at screening and at admission to the clinical research unit.
- Able to sign and date the informed consent document, indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Received a thorough explanation of the mandatory pharmacogenomic research component of the study and has signed the separate pharmacogenomic informed consent document.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion
- Extensive restrictions on the type of food and drink allowed
- Medical history that precludes inclusion in the trial per protocol
- History of allergy and/or sensitivity to loperamide HCl
- History of alcohol consumption that precludes inclusion in the trial per protocol
- Positive screening test for HIV, Hepatitis B or Hepatitis C
- Treatment with an investigational drug within 30 days preceding the first dose of study medication
- Females who are pregnant, nursing, or unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in the protocol
- Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives prior to first dose
- Donated or lost blood or blood products within 3 months of first dose or intention to donate blood or blood products within one month after the last dose
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- Unwillingness or inability to comply with the Lifestyle Guidelines listed in the protocol
- Relationship to persons involved directly with the conduct of the study
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00806299
Start Date
November 1 2008
End Date
November 1 2008
Last Update
October 6 2011
Active Locations (1)
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1
Cetero Research
Fargo, North Dakota, United States, 58104