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What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - adult healthy volunteers Exclusion Criteria: - 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Healthy Volunteers

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:pineapple juice (Carrefour n°1) 500 ml/day 5 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

diclofenac without pineapple juicesingle dose of diclofenac 25 mg without pre-exposure to pineapple juice

diclofenac with pineapple juicesingle dose of diclofenac 25 mg with pre-exposure to pineapple juice

Study Status

Unknown status

Start Date: September 2012

Completed Date: October 2012

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: a) AUC 4-OH-diclofenac / AUC diclofenac quantified in plasma, on days 1 (without pineapple juice) and 11 (after pretreatment with pineapple juice)

Secondary Outcome: (b) AUC 4-OH-diclofenac/ AUC diclofenac quantified in urine, on days 1 (without pineapple juice) and 11 (after pretreatment with pineapple juice)

Study sponsors, principal investigator, and references

Principal Investigator: Isabel Spriet, PharmD PhD

Lead Sponsor: Universitaire Ziekenhuizen Leuven

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01649492