Biological Availability Clinical Trial
Official title:
An Open Label, Randomized, Four-way Crossover Study in Healthy Male Subjects to Assess the Relative Bioavailability of Sorafenib Tablet for Oral Suspension Compared to Marketed Tablet and to Investigate the Pharmacokinetics of Sorafenib Tablet for Oral Suspension Including Food Effect and Dose Proportionality
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
n/a
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