Magnetic marker monitoring (MMM) study with gel matrix tablets under fasting and fed conditions - MMM

Study identifier:D1840M00017

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Magnetic Marker Monitoring

Phase

Phase 1

Healthy volunteers

Yes

Study drug

D1000078, D1000082, D1000083, D1000085

Sex

Male

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Oct 2010

Primary Completion Date: 01 Nov 2010

Study Completion Date: 01 Nov 2010

Study design

Allocation: Randomized
Endpoint Classification: N/A
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2010 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Berlin, Germany

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

"There is no result for the study"

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

+46-31-7761645

erik.soderlind@astrazeneca.com

Investigators

Principal Investigator

Frank Donath

Socra Tec R&D GmbH, Clinical Pharmacology Unit