Study identifier:D4300C00020
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Healthy Volunteers
Phase 1
Yes
MCC-based 13% drug loaded tablets, Mannitol-based 38% drug-loaded tablet
All
88
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Jan 2014 by AstraZeneca
AstraZeneca
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A study in Healthy Volunteers to Compare the Amount of R406 in Blood When Given Different Formulations of Fostamatinib.
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. Treatment sequences will be determined using two 2-2 crossover designs in sequence, 1 for treatments A and B, and 1 for treatments C and D. The order of the designs containing AB/BA and CD/DC within the overall design, as well as the order of treatments within each design, will be randomized. This gives a total of 8 possible treatment sequences as follows: ABCD, ABDC, BACD, BADC, CDAB, CDBA, DCAB, DCBA.
Location
Location
OVERLAND PARK, KS, United States
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 |
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