NCT01319006

Relative Bioavailability Study for GSK1278863A

A Randomized, Open-label, 3-period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of Single Oral 100mg Doses of GSK1278863A

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A randomized, open-label, 3-period crossover study.

Detailed description

A randomized, open label, 3-period crossover study in healthy subjects. The primary objective of this study is to determine the relative bioavailability of GSK1278863A after single oral doses of 100mg GSK1278863A tablets with particle sizes of 13, 29, or 41 micrometers (um) in healthy subjects.

Conditions

• Anaemia

Interventions

Type	Name	Description
DRUG	GSK1278863A	100mg (x90=13um), oral tablet, single-dose with 7 day wash-out
DRUG	GSK1278863A	100mg (x90=29um), oral tablet, single-dose with 7 day wash-out
DRUG	GSK1278863A	100mg (x90=41um), oral tablet, single-dose with 7 day wash-out

Timeline

• Start date: 2011-02-25
• Primary completion: 2011-04-18
• Completion: 2011-04-18
• First posted: 2011-03-21
• Last updated: 2017-06-26

Locations

1 site across 1 country: United States