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Supersaturation and Precipitation of Diclofenac in the Stomach of Healthy Volunteers (DDD13DICLO)

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ClinicalTrials.gov Identifier: NCT02007161
Recruitment Status : Unknown
Verified December 2013 by Jens Van Den Abeele, KU Leuven.
Recruitment status was:  Not yet recruiting
First Posted : December 10, 2013
Last Update Posted : December 11, 2013
Sponsor:
Information provided by (Responsible Party):
Jens Van Den Abeele, KU Leuven

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

Condition or disease Intervention/treatment Phase
Supersaturation and Precipitation in the Stomach Drug: Diclofenac potassium 50 mg Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Supersaturation and Precipitation of Diclofenac in the Stomach of Healthy Volunteers
Study Start Date : December 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014


Arm Intervention/treatment
Active Comparator: Nutritional State

Fed vs. Fasted State

Diclofenac potassium 50 mg

Drug: Diclofenac potassium 50 mg
Diclofenac potassium 50 mg
Other Name: Cataflam

Active Comparator: Use of a PPI

Nexiam (esomeprazole) 40 mg

Diclofenac potassium 50 mg

Drug: Diclofenac potassium 50 mg
Diclofenac potassium 50 mg
Other Name: Cataflam




Primary Outcome Measures :
  1. Area under the Concentration - Time Curve [ Time Frame: Every 10 minutes for 2 h ]


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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Age 20 - 35 years

Exclusion Criteria:

  • Illness
  • 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

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Responsible Party: Jens Van Den Abeele, dhr., KU Leuven
ClinicalTrials.gov Identifier: NCT02007161     History of Changes
Other Study ID Numbers: EudraCT 2013-004636-29
First Posted: December 10, 2013    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action