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Completed

NCT Number: NCT01224587

Magnetic Marker Monitoring (MMM) Study With Gel Matrix Tablets 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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D1000078

Drug

Oral, one single dose

D1000082

Drug

Oral, one single dose

D1000083

Drug

Oral, one single dose

D1000085

Drug

Oral, one single dose

Primary outcomes

  1. The time from an administration of each of the placebo gel matrix tablets of each arm until Gastric Emptying Time (GET)

  2. The time from an administration of each of the placebo gel matrix tablets of each arm until Colon Arrival Time (CAT)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: MMM

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 20, 2010
Registry last updated
Nov 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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