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

C

Catholic University (KU) of Leuven

Status

Unknown

Conditions

Supersaturation and Precipitation in the Stomach

Treatments

Drug: Diclofenac potassium 50 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT02007161
EudraCT 2013-004636-29

Details and patient eligibility

About

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

Enrollment

10 estimated patients

Sex

All

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Nutritional State
Active Comparator group
Description:
Fed vs. Fasted State Diclofenac potassium 50 mg
Treatment:
Drug: Diclofenac potassium 50 mg
Use of a PPI
Active Comparator group
Description:
Nexiam (esomeprazole) 40 mg Diclofenac potassium 50 mg
Treatment:
Drug: Diclofenac potassium 50 mg

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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