Relative Bioavailability of Sorafenib Tablet for Oral Suspension

Status Completed

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

Biological Availability

Clinical Trial Details

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

View Details

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