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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01224587
First received: October 12, 2010
Last updated: November 3, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Magnetic Marker Monitoring
Gastrointestinal-transport
Gastric Emptying Time
Small Intestinal Transit Time
Time for Colon Arrival
Food Effect
 Drug: D1000078
Drug: D1000082
Drug: D1000083
Drug: D1000085
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The time from an administration of each of the placebo gel matrix tablets of each arm until Gastric Emptying Time (GET) [ Designated as safety issue: No ]
  • The time from an administration of each of the placebo gel matrix tablets of each arm until Colon Arrival Time (CAT) [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: October 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
D1000078 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172),AstraZeneca,Mölndal, Sweden , under fasting condition
 Drug: D1000078
Oral, one single dose
Experimental: 2
D1000082 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fasting condition
 Drug: D1000082
Oral, one single dose
Experimental: 3
D1000083 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden ,under fasting condition
 Drug: D1000083
Oral, one single dose
Experimental: 4
D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden , under fasting condition
 Drug: D1000085
Oral, one single dose
Experimental: 5
D100083 marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fed condition
 Drug: D1000083
Oral, one single dose
Experimental: 6
D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca, Mölndal, Sweden , under fed condition
 Drug: D1000085
Oral, one single dose

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224587

Locations
Germany
Research Site
Berlin, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Frank Donath, MD Socra Tec R&D GmbH, Clinical Pharmacology Unit
Study Chair: Maria Anschütz Socra Tec R&D GmbH
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01224587     History of Changes
Other Study ID Numbers: D1840M00017
Study First Received: October 12, 2010
Last Updated: November 3, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by AstraZeneca:
Imaging technique
gastric transport through the gut

ClinicalTrials.gov processed this record on May 22, 2013