- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01224587
Magnetic Marker Monitoring (MMM) Study With Gel Matrix Tablets Under Fasting and Fed Conditions (MMM)
November 3, 2010 updated by: AstraZeneca
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Berlin, Germany
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
D1000078 placebo gel matrix tablet marked with approx.
5 mg Fe3O4(E172),AstraZeneca,Mölndal, Sweden , under fasting condition
|
Oral, one single dose
|
Experimental: 2
D1000082 placebo gel matrix tablet marked with approx.
5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fasting condition
|
Oral, one single dose
|
Experimental: 3
D1000083 placebo gel matrix tablet marked with approx.
5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden ,under fasting condition
|
Oral, one single dose
|
Experimental: 4
D1000085 placebo gel matrix tablet marked with approx.
5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden , under fasting condition
|
Oral, one single dose
|
Experimental: 5
D100083 marked with approx.
5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fed condition
|
Oral, one single dose
|
Experimental: 6
D1000085 placebo gel matrix tablet marked with approx.
5 mg Fe3O4(E172), AstraZeneca, Mölndal, Sweden , under fed condition
|
Oral, one single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Frank Donath, MD, Socra Tec R&D GmbH, Clinical Pharmacology Unit
- Study Chair: Maria Anschütz, Socra Tec R&D GmbH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
October 12, 2010
First Submitted That Met QC Criteria
October 19, 2010
First Posted (Estimate)
October 20, 2010
Study Record Updates
Last Update Posted (Estimate)
November 4, 2010
Last Update Submitted That Met QC Criteria
November 3, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- D1840M00017
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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