A Study to Evaluate the Effect of Food, Formulation Strength, and a Proton Pump Inhibitor on GED 0301 Pharmacokinetics in Healthy Adult Subjects

Summary

This is an open label, single-center, 4-period, 6-sequence study in healthy subjects to compare the PK of GED 0301 after a single oral dose in the fed and fasted state, and after co administration with omeprazole, a proton pump inhibitor. The study will consist of a screening phase, a baseline phase, four treatment periods, and a follow up phone call five days (± 1 day) after discharge.

Timeline

Start

2016-11

Primary completion

2016-12

Completion

2016-12

Drugs

Indications

No indication recorded.