Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sorafenib (BAY43-9006) Film-coated tablet
Sorafenib Film-coated · 1 trial · 1 indication
Area under the concentration versus time curve from zero to the last data point greater than LLOQ after single dose of sorafenib were measured. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Maximum observed drug concentration after single dose administration of sorafenib in plasma was measured. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
| Arm | Type | Description |
|---|---|---|
| Treatment A-C-B-D | EXPERIMENTAL | Subjects received a single oral dose of 400 mg sorafenib marketed tablets (2 \* 200 mg) in fasting state (Treatment A) in the first intervention period; followed by a single oral dose of 200 mg sorafenib tablets for oral suspension (2 \* 100 mg) in fasting state (Treatment C) in the second intervention period; followed by a single oral dose of 400 mg sorafenib tablets for oral suspension (4 \* 100 mg) in fasting state (Treatment B) in the third intervention period; and then a single oral dose of 400 mg sorafenib tablets for oral suspension (4 \* 100 mg) after a high-fat, high-calorie breakfast (fed state) (Treatment D) in the fourth intervention period. A washout period of at least 10 days was maintained between sorafenib administrations. |
| Treatment B-A-D-C | EXPERIMENTAL | Subjects received a single oral dose of 400 mg sorafenib tablets for oral suspension (4 \* 100 mg) in fasting state (Treatment B) in the first intervention period; followed by a single oral dose of 400 mg sorafenib marketed tablets (2 \* 200 mg) in fasting state (Treatment A) in the second intervention period; followed by a single oral dose of 400 mg sorafenib tablets for oral suspension (4 \* 100 mg) after a high-fat, high-calorie breakfast (fed state) (Treatment D) in the third intervention period; and then a single oral dose of 200 mg sorafenib tablets for oral suspension (2 \* 100 mg) in fasting state (Treatment C) in the fourth intervention period. A washout period of at least 10 days was maintained between sorafenib administrations. |
| Treatment C-D-A-B | EXPERIMENTAL | Subjects received a single oral dose of 200 mg sorafenib tablets for oral suspension (2 \* 100 mg) in fasting state (Treatment C) in the first intervention period; followed by a single oral dose of 400 mg sorafenib tablets for oral suspension (4 \* 100 mg) after a high-fat, high-calorie breakfast (fed state) (Treatment D) in the second intervention period; followed by a single oral dose of 400 mg sorafenib marketed tablets (2 \* 200 mg) in fasting state (Treatment A) in the third intervention period; and then a single oral dose of 400 mg sorafenib tablets for oral suspension (4 \* 100 mg) in fasting state (Treatment B) in the fourth intervention period. A washout period of at least 10 days was maintained between sorafenib administrations. |
| Treatment D-B-C-A | EXPERIMENTAL | 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) (Treatment D) in the first intervention period; followed by a single oral dose of 400 mg sorafenib tablets for oral suspension (4 \* 100 mg) in fasting state (Treatment B) in the second intervention period; followed by a single oral dose of 200 mg sorafenib tablets for oral suspension (2 \* 100 mg) in fasting state (Treatment C) in the third intervention period; and then a single oral dose of 400 mg sorafenib marketed tablets (2 \* 200 mg) in fasting state (Treatment A) in the fourth intervention period. A washout period of at least 10 days was maintained between sorafenib administrations. |
| Name | Type | Description |
|---|---|---|
| Sorafenib (BAY43-9006) Film-coated tablet | DRUG | Subjects received a single oral dose of 400 mg sorafenib marketed tablets (2 \* 200 mg) in fasting state in Treatment A |
| Sorafenib (BAY43-9006) Oral suspension | DRUG | 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. |
Inclusion Criteria: * Healthy male subjects between the ages of 18 (inclusive) and 45 years (inclusive) at the first screening visit. * Body mass index (BMI) between 18.0 (inclusive) and 32.0 kg / m² (inclusive). * Non-smoker or former smoker who has stopped smoking at least 3 months before the fir...