- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02117869
The Effect of Low Furanocoumarin Grapefruit Hybrid Juice Consumption on Midazolam Pharmacokinetics
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
As a participant in this study the following will take place: A pre-study visit will be done which will include a physical exam, pregnancy test if applicable, and a review of your medical history. If you qualify you will then undergo three separate study visits as described below.
While participating in this study, participants will not eat grapefruit or other citrus fruits (oranges, lemons, for example) or drink non-study specific grapefruit juice or other citrus fruit juices, or citrus containing foods (orange marmalade, for example) for 1 week prior to each study visit. In addition, no herbal or other dietary supplements or over the counter medications should be taken for 48 hours before and during the study visits.
During each of the three study visits, separated by at least 2 weeks, one of two different grapefruit juice products (either the low furanocoumarin grapefruit hybrid or regular grapefruit) or water will be provided. The order in which these three drinks will be received will be random, like the toss of a coin. Also, 1 dose of midazolam (a drug normally used to make someone sleepy or relaxed before a medical test) will be given during each visit.
Each study visit will consist of three days, on Days 1 and 2 a drink of 200ml (about 7 ounces) of the assigned grapefruit juice or water will be given.
On Day 3 of each study visit, you will fast (abstain from having anything to eat or drink except water) from 12 a.m. the night before, and report to the clinic for the study day at 8am.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32611
- Clinical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-65 years of age
- non-smokers
Exclusion Criteria:
- Inability to abstain from alcoholic beverages (24 hours),
- Inability to abstain herbal containing supplements/teas/beverages, and
- Inability to abstain from over-the-counter medications (48 hours) prior to the study visits
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low furanocoumarin hybrid grapefruit juice
3 consecutive daily doses of 200ml low furanocoumarin hybrid grapefruit juice plus midazolam 5mg orally on the third day.
|
3 consecutive daily doses of 200ml low furanocoumarin grapefruit juice plus midazolam 5mg orally on the third day.
|
Active Comparator: Regular grapefruit juice
3 consecutive daily doses of 200ml regular grapefruit juice plus midazolam 5mg orally on the third day.
|
3 consecutive daily doses of 200ml regular grapefruit juice plus midazolam 5mg orally on the third day.
|
Other: water (control)
3 consecutive daily doses of 200ml water plus midazolam 5mg orally on the third day.
|
3 consecutive daily doses of 200ml water plus midazolam 5mg orally on the third day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the plasma concentration-time curves
Time Frame: Approximately 9 hours
|
For pharmacokinetic analysis, venous blood samples from an intravenous catheter in the arm will be collected prior to (0 hr, predose), and at 0.5, 1, 2, 3, 4, 6, and 9 hours after midazolam administration.
|
Approximately 9 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to peak concentration
Time Frame: Approximately 9 hours
|
For pharmacokinetic analysis, venous blood samples from an intravenous catheter in the arm will be collected prior to (0 hr, predose), and at 0.5, 1, 2, 3, 4, 6, and 9 hours after midazolam administration.
|
Approximately 9 hours
|
Peak concentration
Time Frame: Approximately 9 hours
|
For pharmacokinetic analysis, venous blood samples from an intravenous catheter in the arm will be collected prior to (0 hr, predose), and at 0.5, 1, 2, 3, 4, 6, and 9 hours after midazolam administration.
|
Approximately 9 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rhonda M Copper-DeHoff, PharmD, MS, University of Florida
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201300728
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pharmacokinetics
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Subjects | Pharmacokinetics of Isavuconazole | Pharmacokinetics of Methotrexate | Pharmacokinetics of 7-hydroxymethotrexateUnited States
-
Astellas Pharma IncCompletedHealthy | Pharmacokinetics of ASP1941 | Pharmacokinetics of MitiglinideJapan
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Volunteers | Pharmacokinetics of Isavuconazole | Pharmacokinetics of MethadoneUnited States
-
Astellas Pharma IncBasilea PharmaceuticaCompletedHealthy Volunteers | Pharmacokinetics of Isavuconazole | Pharmacokinetics of MidazolamUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Volunteers | Pharmacokinetics of Isavuconazole | Pharmacokinetics of DigoxinUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Volunteers | Pharmacokinetics of Isavuconazole | Pharmacokinetics of BupropionUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Subjects | Pharmacokinetics of Isavuconazole | Pharmacokinetics of SirolimusUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Volunteers | Pharmacokinetics of Isavuconazole | Pharmacokinetics of AtorvastatinUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Subjects | Pharmacokinetics of Caffeine | Pharmacokinetics of RepaglinideUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Subjects | Pharmacokinetics of Isavuconazole | Pharmacokinetics of MetforminUnited States
Clinical Trials on Low furanocoumarin hybrid grapefruit juice
-
Johnson & Johnson Consumer and Personal Products...Completed
-
Vanderbilt UniversityCompleted
-
Nemours Children's ClinicMerck Sharp & Dohme LLCCompleted
-
Children's Hospital of PhiladelphiaWithdrawn
-
University Hospital, Clermont-FerrandFRANCE; UMR 1019 Unité de Nutrition Humaine; INRA de Clermont-Fd / Theix; Equipe... and other collaboratorsCompletedPost-menopausal StatusFrance
-
Shirley M. TsunodaUnknownKidney Transplant; Complications | Drug Interaction Food
-
Haukeland University HospitalCompleted
-
Boehringer IngelheimCompleted
-
USDA Grand Forks Human Nutrition Research CenterCompletedOverweightUnited States