Pharmacokinetics of Proton Pump Inhibitors in a random Icelandic Populatio
Phase 1
- Conditions
- Gastro Oesophageal Reflux DiseaseTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2015-002230-41-IS
- Lead Sponsor
- andspitali University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
We plan to recruit 30 healthy participants, with age 20 - 50 years, and equally many males and females.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
* Subjects taking known CYP (Cytochromes P450) inhibitors or inducers
* Known history of gastro oesophageal reflux symptoms
* Impaired hepatic and/or renal function
* Known H. pylori infection and/or other infectious diseases
* Known alcohol and/or substance abuse
* Pregnancy
* BMI > 30
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this work is to identify the pharmacokinetics of proton pump inhibitors (PPI) after a single oral dose and after continuous intake for five days in healthy volunteers. ;Secondary Objective: The secondary objective of this work is to increase the understanding of the contribution of factors such as demographics to variability in the pharmacokinetics of PPIs in a random Icelandic population. ;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA
- Secondary Outcome Measures
Name Time Method Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA