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

NCT ID: NCT01224587

Last Updated: 2010-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2010-11-30

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.

Detailed Description

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Conditions

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

Keywords

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Imaging technique gastric transport through the gut

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

D1000078 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172),AstraZeneca,Mölndal, Sweden , under fasting condition

Group Type EXPERIMENTAL

D1000078

Intervention Type DRUG

Oral, one single dose

2

D1000082 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fasting condition

Group Type EXPERIMENTAL

D1000082

Intervention Type DRUG

Oral, one single dose

3

D1000083 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden ,under fasting condition

Group Type EXPERIMENTAL

D1000083

Intervention Type DRUG

Oral, one single dose

4

D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden , under fasting condition

Group Type EXPERIMENTAL

D1000085

Intervention Type DRUG

Oral, one single dose

5

D100083 marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fed condition

Group Type EXPERIMENTAL

D1000083

Intervention Type DRUG

Oral, one single dose

6

D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca, Mölndal, Sweden , under fed condition

Group Type EXPERIMENTAL

D1000085

Intervention Type DRUG

Oral, one single dose

Interventions

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D1000078

Oral, one single dose

Intervention Type DRUG

D1000082

Oral, one single dose

Intervention Type DRUG

D1000083

Oral, one single dose

Intervention Type DRUG

D1000085

Oral, one single dose

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Frank Donath, MD

Role: PRINCIPAL_INVESTIGATOR

Socra Tec R&D GmbH, Clinical Pharmacology Unit

Maria Anschütz

Role: STUDY_CHAIR

Socra Tec R&D GmbH

Locations

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Research Site

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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D1840M00017

Identifier Type: -

Identifier Source: org_study_id