A Study to Assess the Bioequivalence of R406 in Healthy Volunteers when given 100mg and 150 mg of Fostamatinib - Fosta BE
Study identifier:D4300C00020
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open-label, Single-center, Randomized, 4-way Crossover Study to Assess the Bioequivalence of R406 in Healthy Volunteers when 100 and 150mg of Fostamatinib are Administered as the 13% Drug-loaded Tablet Versus the 38% Drug-loaded Tablet
Medical condition
Healthy Volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
MCC-based 13% drug loaded tablets, Mannitol-based 38% drug-loaded tablet
Sex
All
Actual Enrollment
88
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Jul 2012
Primary Completion Date: 01 Mar 2013
Study Completion Date: 01 Mar 2013
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Jan 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment A 100mg MCC-based 13% drug-loaded tablets | Drug: MCC-based 13% drug loaded tablets 50mg tablets, dosed as 2 tablets (100mg total) |
| Experimental: Treatment B 100mg mannitol-based 38% drug-loaded tablets | Drug: Mannitol-based 38% drug-loaded tablet One 100mg tablet |
| Experimental: Treatment C 150mg MCC-based 13% drug-loaded tablets | Drug: MCC-based 13% drug loaded tablets 3 tablets (150mg total) |
| Experimental: Treatment D 150mg mannitol-based 38% drug-loaded tablets | Drug: Mannitol-based 38% drug-loaded tablet One 150 mg tablet |
Contacts
Investigators
Principal Investigator
Chris O'Brien
AstraZeneca
