E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
healthy human volunteers (administration of a proton-pump inhibitor) |
Gezonde vrijwilligers (toediening van een proton-pomp inhibitor) |
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E.1.1.1 | Medical condition in easily understood language |
Healthy human volunteers
|
Gezonde vrijwilligers |
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E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
This study is part of a larger study which aims to collect and characterise stomach and duodenal fluids in different populations and conditions. The part of the study concerned for the EudraCT file is the test condition in which the effect of proton-pomp inhibtor use on the composition of gastrointestinal fluids of healthy human volunteers is investigated. |
Deze studie is onderdeel van een grotere studie met als doel het collecteren en karakteriseren van maag- en darmvochten in verschillende populaties en onder verschillende experimentele condities. Het deel van de studie dat onderwerp uitmaakt van dit EudraCT formulier is de test conditie waarbij de invloed van het gebruik van proton-pomp inhibitoren op de samenstelling van gastrointestinale vochten van gezonde vrijwilligers wordt onderzocht. |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
Niet van toepassing |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy human volunteers (age: 18 - 80 years)
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Gezonde vrijwilligers (leeftijd: 18 - 80 jaar)
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E.4 | Principal exclusion criteria |
- (possible) pregnancy - frequent exposure to xrays during the past year - HIB, HBV, HCV infection
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- (mogelijke) zwangerschap - frequente blootstelling aan röntgenstralen gedurende het voorbije jaar - HIV, HBV, HCV infectie
|
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E.5 End points |
E.5.1 | Primary end point(s) |
Not applicable |
Niet van toepassing |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Niet van toepassing |
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E.5.2 | Secondary end point(s) |
Not applicable |
Niet van toepassing |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Niet van toepassing |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
This study aims to investigate possible differences in composition of gastrointestinal fluids betweens different populations and under different experimental conditions. Subsequently, the impact of possible differences in composition on the behavior of drugs in the GI tract will be investigated in vitro |
Deze studie heeft tot doel verschillen in samenstelling van gastrointestinale vochten tussen verschillende populaties en onder verschillende experimentele condities te onderzoeken. Vervolgens zal in vitro nagegaan worden in welke mate eventuele verschillen in samenstelling het gedrag van geneesmiddelen in het GI stelsel beïnvloeden. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Invloed van proton-pomp inhibitor (PPI) gebruik op de samenstelling GI vochten vs. geen PPI gebruik |
Influence of proton-pump inhibitor (PPI) use on GI fluid composition vs. no PPI use |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |