Pharmacokinetics of Proton Pump Inhibitors in a random Icelandic Population

Pharmacokinetics of Proton Pump Inhibitors in a random Icelandic Population.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002230-41-IS

Enrollment

Registered

2015-06-05

Start date

2015-06-29

Completion date

Unknown

Last updated

2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro Oesophageal Reflux Disease

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Iceland

Contacts

Public ContactEinar Stefan Bjornsson

Landspitali University Hospital

einarsb@landspitali.is

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026