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Clinical Trials/NCT02007161
NCT02007161UnknownNot Applicable

Supersaturation and Precipitation of Diclofenac in the Stomach of Healthy Volunteers

KU Leuven0 sites10 target enrollmentStarted: December 2013Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Sponsor
KU Leuven
Enrollment
10
Primary Endpoint
Area under the Concentration - Time Curve
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Investigate the supersaturation and precipitation behaviour of diclofenac in the stomach of healthy volunteers.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
20 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Healthy volunteers
  • •Age 20 - 35 years

Exclusion Criteria

  • •Acute / Chronic gastric disorder
  • •Use of medicine
  • •(possible) pregnancy
  • •Frequent exposure to X-rays during the past year
  • •HIV / Hepatitis B Virus or Hepatitis C Virus infection

Arms & Interventions

Nutritional State

Active Comparator

Fed vs. Fasted State

Diclofenac potassium 50 mg

Intervention: Diclofenac potassium 50 mg (Drug)

Use of a PPI

Active Comparator

Nexiam (esomeprazole) 40 mg

Diclofenac potassium 50 mg

Intervention: Diclofenac potassium 50 mg (Drug)

Outcomes

Primary Outcomes

Area under the Concentration - Time Curve

Time Frame: Every 10 minutes for 2 h

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
KU Leuven
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jens Van Den Abeele

dhr.

KU Leuven

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