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

AstraZeneca5 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

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

Interventions

D1000078DRUG

Oral, one single dose

D1000082DRUG

Oral, one single dose

D1000083DRUG

Oral, one single dose

D1000085

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Berlin, Germany

Outcomes

Primary Outcomes

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)

Data from ClinicalTrials.gov

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