Supersaturation and Precipitation of Diclofenac in the Stomach of Healthy Volunteers

Not Applicable

• Conditions: Supersaturation and Precipitation in the Stomach
• Interventions: Drug: Diclofenac potassium 50 mg

• Registration Number: NCT02007161
• Lead Sponsor: KU Leuven

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-12
• Study Start: 2013-12
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-10
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-11
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Use of a PPI	Diclofenac potassium 50 mg	Nexiam (esomeprazole) 40 mg Diclofenac potassium 50 mg
Nutritional State	Diclofenac potassium 50 mg	Fed vs. Fasted State Diclofenac potassium 50 mg

Primary Outcome Measures

Name	Time	Method
Area under the Concentration - Time Curve	Every 10 minutes for 2 h