Supersaturation and Precipitation of Diclofenac in the Stomach of Healthy Volunteers

Supersaturation and Precipitation in the Stomach Clinical Trial

— DDD13DICLO  

Official title:

Supersaturation and Precipitation of Diclofenac in the Stomach of Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02007161
• Other study ID #: EudraCT 2013-004636-29
• Status: Not yet recruiting
• Phase: N/A
• First received: December 5, 2013
• Last updated: December 10, 2013
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Supersaturation and Precipitation in the Stomach

Intervention

Drug:
• Diclofenac potassium 50 mg
Diclofenac potassium 50 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the Concentration - Time Curve		Every 10 minutes for 2 h	No