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

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)

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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