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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | D1000078 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172),AstraZeneca,Mölndal, Sweden , under fasting condition |
|
| 2 | Experimental | D1000082 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fasting condition |
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| 3 | Experimental | D1000083 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden ,under fasting condition |
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| 4 | Experimental | D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden , under fasting condition |
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| 5 | Experimental | D100083 marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fed condition |
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| 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D1000078 | Drug | Oral, one single dose |
| |
| D1000082 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Donath, MD | Socra Tec R&D GmbH, Clinical Pharmacology Unit | Principal Investigator |
| Maria Anschütz | Socra Tec R&D GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | Germany |
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D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca, Mölndal, Sweden , under fed condition |
|
| Drug |
Oral, one single dose |
|
| D1000083 | Drug | Oral, one single dose |
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| D1000085 | Drug | Oral, one single dose |
|