Magnetic Marker Monitoring (MMM) Study With Gel Matrix Tablets Under Fasting and Fed Conditions

Study Overview
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Brief Summary
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The purpose of this study is to monitor the gastrointestinal transport of eroding gel matrix placebo tablets in healthy male volunteers under fasting and fed conditions. The method which is used is an imaging technique.

Official Title
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Characterisation of Gastrointestinal Transit of Four New Developed Gel Matrix Tablets With Different Erosion Rates by Means of MMM Measurement Under Fasting and Fed Conditions

Conditions
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Magnetic Marker Monitoring, Gastrointestinal-transport, Gastric Emptying Time, Small Intestinal Transit Time, Time for Colon Arrival, Food Effect

Intervention / Treatment
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* Drug: D1000078
* Drug: D1000082
* Drug: D1000083
* Drug: D1000085


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ethnic origin: Caucasian Body-mass index (BMI): ≥ 19 kg/m² and ≤ 27 kg/m² Good health Written informed consent, after having been informed about benefits and potential risks of the trial Exclusion Criteria: Diseases which could influence the gastric emptying and gastrointestinal transport Diet which could influence the gastric emptying and gastrointestinal transport Surgery in the gastrointestinal tract which may interfere with the safety and transport of test product Ferromagnetic implants or any other magnetic disturbance, which can affect the Magnetic Marker Monitoring measurement Regular medical treatments which could affect the gastric emptying and gastrointestinal transport

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>D1000078 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172),AstraZeneca,Mölndal, Sweden , under fasting condition | Drug: D1000078<br>* Oral, one single dose<br>|
| Experimental: 2<br>D1000082 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fasting condition | Drug: D1000082<br>* Oral, one single dose<br>|
| Experimental: 3<br>D1000083 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden ,under fasting condition | Drug: D1000083<br>* Oral, one single dose<br>|
| Experimental: 4<br>D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden , under fasting condition | Drug: D1000085<br>* Oral, one single dose<br>|
| Experimental: 5<br>D100083 marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fed condition | Drug: D1000083<br>* Oral, one single dose<br>|
| Experimental: 6<br>D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca, Mölndal, Sweden , under fed condition | Drug: D1000085<br>* Oral, one single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time from an administration of each of the placebo gel matrix tablets of each arm until Gastric Emptying Time (GET) |  |  | 
| The time from an administration of each of the placebo gel matrix tablets of each arm until Colon Arrival Time (CAT) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Imaging technique, gastric transport through the gut