A study to compare two different tablet formulations of AZD8931 in healthy males and females
Study identifier:D0102C00005
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Randomised, Open-label, Cross-over, Single-centre Study in Healthy Male and Non-fertile Female Volunteers to Determine the Relative Bioavailability of the Phase II wet granulation tablet formulation compared to the Phase II/III roller compacted tablet formulation of AZD8931
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD8931
Sex
All
Actual Enrollment
26
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Apr 2011
Primary Completion Date: 01 May 2011
Study Completion Date: 01 May 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other
Verification:
Verified 01 Jan 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 40 mg AZD8931 wet granulation tablet formulation | Drug: AZD8931 40 mg AZD8931 wet granulation tablet formulation |
| Experimental: 40 mg AZD8931 roller compacted tablet formulation | Drug: AZD8931 40 mg AZD8931 roller compacted tablet formulation |
Contacts
Investigators
Principal Investigator
Mary Stuart
AstraZeneca,1F64, Mereside, Alderley Park, Macclesfield, Cheshire,SK10 4TG UK
