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Clinical Trial 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


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02538393
Study type Interventional
Source Bayer
Contact
Status Completed
Phase Phase 1
Start date November 20, 2015
Completion date June 15, 2016

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