In Vivo Inhibition Profile of CYP2C9 by Pineapple Juice
1 other identifier
interventional
10
1 country
1
Brief Summary
The goal of this study is to evaluate the actual potential for in vivo pineapple juice inhibition with CYP2C9 substrates in human volunteers with use of diclofenac as a marker of CYP2C9 activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 healthy-volunteers
Started Sep 2012
Shorter than P25 for phase_4 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2012
CompletedFirst Posted
Study publicly available on registry
July 25, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJuly 25, 2012
July 1, 2012
1 month
July 20, 2012
July 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
a) AUC 4-OH-diclofenac / AUC diclofenac quantified in plasma, on days 1 (without pineapple juice) and 11 (after pretreatment with pineapple juice)
see above
day 1 and day 11
Secondary Outcomes (1)
(b) AUC 4-OH-diclofenac/ AUC diclofenac quantified in urine, on days 1 (without pineapple juice) and 11 (after pretreatment with pineapple juice)
day 1 and day 11
Other Outcomes (1)
c) Bromelain activity quantified in plasma, measured on days 1 and 11
day 1 and day 11
Study Arms (2)
diclofenac without pineapple juice
NO INTERVENTIONsingle dose of diclofenac 25 mg without pre-exposure to pineapple juice
diclofenac with pineapple juice
ACTIVE COMPARATORsingle dose of diclofenac 25 mg with pre-exposure to pineapple juice
Interventions
Eligibility Criteria
You may qualify if:
- adult healthy volunteers
You may not qualify if:
- younger than 18 yrs
- older than 60 yrs
- pregnant or lactating women
- medical history of gastric or duodenal ulcers, gastro-oesofageal reflux disease, dyspepsia, asthma, any allergy to NSAIDS
- patients taking co-medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Leuven
Leuven, 3000, Belgium
Study Officials
- PRINCIPAL INVESTIGATOR
Isabel Spriet, PharmD PhD
Pharmacy Dpt, University Hospitals Leuven
- STUDY CHAIR
Hans Prenen, MD PhD
Digestive Oncology, University Hospitals Leuven
- STUDY CHAIR
Vincent Vandecaveye, MD PhD
Radiology Dpt, University Hospitals Leuven
- STUDY CHAIR
Pieter Annaert, PharmD PhD
Laboratory for Pharmacotechnology and Biopharmacy, Catholic University Leuven
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PharmD, PhD
Study Record Dates
First Submitted
July 20, 2012
First Posted
July 25, 2012
Study Start
September 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
July 25, 2012
Record last verified: 2012-07