Relative Bioavailability of Sorafenib Tablet for Oral Suspension

Summary

The primary objective of the study is to • Investigate the relative bioavailability of sorafenib as 400 mg (4 x 100 mg) tablet for oral suspension formulation in comparison to 400 mg (2 x 200 mg) marketed tablet formulation. The secondary objectives of this study are to * Evaluate the dose proportionality in sorafenib pharmacokinetics for sorafenib tablet for oral suspension formulation after administration of 200 mg (2 x 100 mg) and 400 mg (4 x 100 mg) dose of sorafenib in fasted state * Evaluate the effect of food on the pharmacokinetics of the tablet for oral suspension formulation after administration of a single dose of 400 mg sorafenib (4 x 100mg) * Evaluate the taste and palatability of sorafenib (both formulations) * Assess the safety and tolerability of sorafenib tablet for oral suspension in healthy male subjects

Timeline

Start

2015-11-20

Primary completion

2016-03-15

Completion

2016-06-15

Drugs

Indications

No indication recorded.