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 (Fosta BE)

NCT01645085 Phase 1 COMPLETED

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

Details

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	COMPLETED
Enrolment	88
Start date	2012-07
Completion	2013-03

Conditions

• Healthy Volunteers

Interventions

• MCC-based 13% drug loaded tablets
• Mannitol-based 38% drug-loaded tablet
• MCC-based 13% drug loaded tablets
• Mannitol-based 38% drug-loaded tablet

Primary outcomes

• Bioequivalence of R406 when fostamatinib is administered as two 50mg MCC-based 13% drug-loaded tablets versus one 100mg mannitol-based 38% drug-loaded tablet — Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose
• Bioequivalence of R406 when fostamatinib is administered as three 50mg MCC-based 13% drug-loaded tablets versus one 150mg mannitol-based 38% drug-loaded tablet — Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose

Countries

United States