Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy Subjects

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
AstraZeneca
Study ID
NCT01309854
Phase
PHASE1
Status
Completed

Conditions

  • Amount of Pioglitazone in Blood
  • Drug-drug Interaction
  • Healthy Volunteers
  • Pharmacokinetics
  • Pioglitazone
  • Rheumatoid Arthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • fostamatinib — DRUG
    oral tablets, 100mg (2 X 50mg) twice daily for 8 days
  • pioglitazone — DRUG
    oral tablets, 30mg single dose per period

Study Details

The purpose of this study is to investigate the drug interaction between fostamatinib and pioglitazone by comparing the safety, tolerability and plasma concentration of pioglitazone when administered alone and with fostamatinib in healthy subjects.

Key Dates

Start date
Mar 31, 2011
Status verified
Jul 2011
Primary completion
May 31, 2011
Completion
May 31, 2011

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: pioglitazone
  • Experimental: pioglitazone and fostamatinib

Primary Outcome Measure

To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax [ Time Frame: Period 1: Pre-dose to 48h post dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteOverland ParkKansas--

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