To evaluate the bioavailability of a tablet of AZD1656
Study identifier:D1020C00010
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomized, Open, Single-Dose, Single-Centre, cross-over, Phase I Study in type 1 diabetes mellitus patients to estimate the extent and rate of absorption of AZD1656 after administration of a tablet formulation in the fasting state and just before food in comparison with an oral suspension of AZD1
Medical condition
Type 1 Diabetes
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD1656
Sex
All
Actual Enrollment
11
Study type
Interventional
Age
20 Years - 65 Years
Date
Study Start Date: 01 Dec 2008
Primary Completion Date: 01 Mar 2009
Study Completion Date: 01 Sept 2009
Study design
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 AZD1656 tablet + food | Drug: AZD1656 Single dose oral tablet Drug: AZD1656 Single dose oral suspension |
| Active Comparator: 2 AZD1656 susp. without food | Drug: AZD1656 Single dose oral tablet Drug: AZD1656 Single dose oral suspension |
| Active Comparator: 3 AZD1656 tablet | Drug: AZD1656 Single dose oral tablet Drug: AZD1656 Single dose oral suspension |
Contacts
Investigators
Principal Investigator
Klas Malmberg
AstraZeneca R&D Mölndal
