Assess Pharmacokinetics of Fostamatinib in fed and fasted state in combination with Ranitidine to assess bioavailability - PK Combination

Study identifier:D4300C00019

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open-label, Single-center, 2-Part, Randomized Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets

Medical condition

pharmacokinetics

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference), Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed, Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A), Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B), Ranitidine

Sex

All

Actual Enrollment

28

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Sept 2012
Primary Completion Date: 01 Dec 2012
Study Completion Date: 01 Dec 2012

Study design

Allocation: Randomized
Endpoint Classification: Safety 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