Relative Bioavailability of Sorafenib Tablet for Oral Suspension

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 20, 2015

Primary Completion Date

March 15, 2016

Study Completion Date

June 15, 2016

Conditions
Biological Availability
Interventions
DRUG

Sorafenib (BAY43-9006) Film-coated tablet

Subjects received a single oral dose of 400 mg sorafenib marketed tablets (2 \* 200 mg) in fasting state in Treatment A

DRUG

Sorafenib (BAY43-9006) Oral suspension

Treatment C: Subjects received a single oral dose of 200 mg sorafenib tablets for oral suspension (2 \* 100 mg) in fasting state in the second intervention period; Treatment B: Subjects received a single oral dose of 400 mg sorafenib tablets for oral suspension (4 \* 100 mg) in fasting state in the third intervention period; Treatment D: Subjects received a single oral dose of 400 mg sorafenib tablets for oral suspension (4 \* 100 mg) after a high-fat, high-calorie breakfast (fed state) in the fourth intervention period.

Trial Locations (1)

13353

Berlin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY