E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers |
Gezonde vrijwilligers |
|
E.1.1.1 | Medical condition in easily understood language |
Healthy volunteers |
Gezonde vrijwilligers |
|
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 |
The general aim is to assess the pharmacokinetic disposition of mesalazine in the colon of healthy volunteers. To this end, the present study persues the optimization of the sampling (time and procedure) of colonic fluids and tissue by ileocolonoscopy after intraduodenal delivery of a single dose of Pentasa. Four sampling times will be evaluated using a cross-over design. |
Het globale doel is de evaluatie van de dispositie van mesalazine in het colon van gezonde vrijwilligers. Om dit te realiseren beoogt de huidige studie de optimalisering van de afname (tijdstip en procedure) van colonvochten en -weefsel met behulp van ileocolonoscopie na intraduodenale toediening van een eenmalige dosis Pentasa. Vier tijdstippen van ileocolonoscopie zullen worden vergeleken via een cross-over design. |
|
E.2.2 | Secondary objectives of the trial |
Not applicable |
Niet van toepassing |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
healthy volunteers age: 18 - 35 years old |
gezonde vrijwilligers leeftijd: 18-35 jaar |
|
E.4 | Principal exclusion criteria |
- allergy for salicylic acid derivatives - acute/chronic GI condition - diabetes, cardiovasular/pulmonary/renal diseases - use of medication (except contraception) - (possible) pregnancy - smoking - HIV / HBV / HCV infection |
• allergie voor salicylzuurderivaten • acute/chronische maagdarmaandoeningen • diabetes, cardiovasculaire, pulmonale of renale aandoeningen • (mogelijke) zwangerschap • Inname geneesmiddelen (exclusief contraceptie) • roken • HIV, HBV of HCV besmetting
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
not applicable |
niet van toepassing |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
not applicable |
niet van toepassing |
|
E.5.2 | Secondary end point(s) |
not applicable |
niet van toepassing |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
not applicable |
niet van toepassing |
|
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 | Yes |
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 | No |
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 | Yes |
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 |
Factor 1: time of sampling of colonic fluids and tissue |
|
E.8.2.4 | Number of treatment arms in the trial | 4 |
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
|
last visit of the last subject |
laatste bezoek van de laatste vrijwilliger |
|
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 | |
E.8.9.1 | In the Member State concerned days | |