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A Study to Assess the Bioequivalence of R406 in Healthy Volunteers When Given 100mg and 150 mg of Fostamatinib

NCT01645085 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2013-03-19

No results posted yet for this study

Summary

A study in Healthy Volunteers to Compare the Amount of R406 in Blood When Given Different Formulations of Fostamatinib.

Conditions

  • Healthy Volunteers

Interventions

DRUG

MCC-based 13% drug loaded tablets

50mg tablets, dosed as 2 tablets (100mg total)

DRUG

Mannitol-based 38% drug-loaded tablet

One 100mg tablet

DRUG

MCC-based 13% drug loaded tablets

3 tablets (150mg total)

DRUG

Mannitol-based 38% drug-loaded tablet

One 150 mg tablet

Sponsors & Collaborators

Principal Investigators

  • Chris O'Brien, MEDICAL SCIENCE DIRECTOR · AstraZeneca

  • David Mathews, MD · Quintiles, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01645085 on ClinicalTrials.gov