Concentration-Time Profiles in Stomach & Intestine. Clinical Trial
Official title:
The Use of a Non-absorbable Marker for the Evaluation of the Gastrointestinal Transit. Evaluatie Van de Gastrointestinale Transit Aan de Hand Van de Niet-absorbeerbare Merker Paromomycine Sulfaat (Dutch Translation)
Aim of the study The aim of this study is to use Gabbroral® oral tablet formulation as
marker for the evaluation of the gastrointestinal transit. By collecting and analyzing both
gastric and intestinal fluids on different time points, the transfer dissolution can be
distracted. For this study stomach fluid and intestinal fluid will be collected after oral
intake of a commercially available dosing form of Paromomycin Sulfate (Gabbroral® oral
tablet formulation), which is dissolved in a glas of 240mL water, in fasted or fed state.
Four intake conditions will be tested on four different test days (with an intermediate
period of at least 7 days).
1. intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of
240mL water, in fasted state.
2. intake of Gabbroral® oral tablet formulation in fed state.
3. Intake of 2 tablets of Motilium® (API: domperidone 10 mg) 20 minutes before the intake
of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL
water.
4. Intake of 2 tablets of Motilium® (API: loperamide HCl 2 mg) 20 minutes before the
intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of
240mL water.
Conduct of the study
- The study consists of four testing days in the University Hospitals Leuven,
Gasthuisberg campus.
- On each test day you come at the agreed time in fasting State to the Gastroenterology
Department at UZ Leuven (Gasthuisberg, floor 0, Orange arrow). Fasted state means that
you have eaten nothing for 12 hours for the investigation and only have been drinking
water.
- A basic clinical anamnesis will be taken by a doctor to make sure that you are a
healthy volunteer for our study. For making sure that you are HIV negative, you will
undergo an HIV test. In case of a female volunteer, a pregnancy test will be taken in
account to make sure you are not pregnant.
- Upon arrival at the hospital through the nose or the mouth two probes: one in the
stomach and one in the gut. The position of both probes is controlled using fluoroscopy
(x-ray).
- After a stabilisation period of ca. 20 min you will be asked for taking a single dose
of Gabbroral® oral tablet formulation. On four different test days, with an
intermediate period of at least 7 days, we will follow every one of following intake
conditions:
1. intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of
240mL water, in fasted state.
2. intake of Gabbroral® oral tablet formulation in fed state.
3. Intake of 2 tablets of Motilium® (API: domperidone 10 mg) 20 minutes before the
intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of
240mL water.
4. Intake of 2 tablets of Motilium® (API: loperamide HCl 2 mg) 20 minutes before the
intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of
240mL water.
- After intake of the medicine at regular intervals, gastrointestinal fluids will be
aspirated over 4 hours. You sit in a comfortable position in bed; eating and sleeping
is not permitted (after 2 hours you have the possibility to drink some water).
- After 4 hours, the gastrointestinal catheters will be removed and you may eat and roam
freely.
| Status | Recruiting |
| Enrollment | 10 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 35 Years |
| Eligibility |
Inclusion Criteria: - Healthy volunteers - age: 20-35 year Exclusion Criteria: - Diseases - Acute/chronic gastrointestinal disorders - Medication use - Possible pregnancy - Frequent exposure to x-ray radiation during the past year - HIV positive |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Gasthuisberg | Leuven | BE |
| Lead Sponsor | Collaborator |
|---|---|
| Katholieke Universiteit Leuven |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Concentration-time profiles of the drug paromomycin sulfate in the stomach and intestine | This concentration-time profiles in the stomach and intestine will be measured for 4 hours. | No |