Status:

COMPLETED

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

Lead Sponsor:

AstraZeneca

Conditions:

Magnetic Marker Monitoring

Gastrointestinal-transport

Eligibility:

MALE

18-55 years

Phase:

PHASE1

Brief Summary

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2010

Estimated Enrollment :

5 Patients enrolled

Trial Details

Trial ID

NCT01224587

Start Date

October 1 2010

End Date

November 1 2010

Last Update

November 4 2010

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Research Site

Berlin, Germany