NCT00924911

Relative Bioavailability Study in Healthy Subjects

A Two Part Single Dose, Randomized, Balanced, Crossover Study to Assess the Relative Bioavailability of Three Formulations, Drug Interaction and Food Effect on an GSK1322322 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Part 1 of this study will assess the relative bioavailability of GSK1322322 administered as one of three investigational tablets compared to powder in a bottle formulation. Pharmacokinetics of these three tablets will be evaluated and the investigation tablet with the optimal PK profile will be progressed to Part 2. In Part 2 the investigational tablet selected from Part 1 will be coadministered with food alone, an H2 blocker alone, or an H2 blocker given in combination with ascorbic acid to evaluate the effect on GSK1322322 pharmacokinetics. Plasma GSK1322322 PK profile, safety, and tolerability will be assessed from each dose group.

Conditions

• Infections, Bacterial

Interventions

Type	Name	Description
DRUG	GSK1322322	Four different formulations of 1000mg of GSK1322322
DRUG	GSK1322322	GSK1322322 1000mg

Timeline

• Start date: 2009-04-27
• Primary completion: 2009-07-09
• Completion: 2009-07-09
• First posted: 2009-06-19
• Last updated: 2017-06-26

Locations

1 site across 1 country: United States