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Relative Bioavailability of Sorafenib Tablet for Oral Suspension

2015-09-03 00:23:23 | BioPortfolio

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Biological Availability

Intervention

Sorafenib (BAY43-9006), Sorafenib (BAY43-9006), Sorafenib (BAY43-9006), Sorafenib (Nexavar, BAY43-9006)

Status

Not yet recruiting

Source

Bayer

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-09-03T00:23:23-0400

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Medical and Biotech [MESH] Definitions

None available.

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