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

Food Effect Clinical Trial

— MMM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224587
• Other study ID #: D1840M00017
• Status: Completed
• Phase: Phase 1
• First received: October 12, 2010
• Last updated: November 3, 2010
• Start date: October 2010
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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 imaging technique.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

Intervention

Drug:
• D1000078
Oral, one single dose
• D1000082
Oral, one single dose
• D1000083
Oral, one single dose
• D1000085
Oral, one single dose

Locations

Country	Name	City	State
Germany	Research Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time from an administration of each of the placebo gel matrix tablets of each arm until Gastric Emptying Time (GET)			No
Primary	The time from an administration of each of the placebo gel matrix tablets of each arm until Colon Arrival Time (CAT)			No