Approval Probability
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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...
Sorafenib Film-coated is a film-coated tablet formulation of sorafenib, a small molecule kinase inhibitor developed by Bayer AG. It is also known as sorafenib (BAY43-9006) film-coated tablet. The film-coated form is studied for oral administration, including as a tablet for oral suspension.
Sorafenib Film-coated targets RAF1, PDGFRB, BRAF, KIT, FLT3, and RET. It is a small molecule inhibitor of these kinases. By inhibiting these targets, sorafenib affects multiple signaling pathways involved in cell proliferation and angiogenesis.
Sorafenib Film-coated is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the originator of sorafenib and its film-coated tablet formulation.
Sorafenib Film-coated is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The Phase 1 program includes one completed trial with 30 participants.
Sorafenib Film-coated has been studied in one completed Phase 1 trial, NCT02538393, titled Relative Bioavailability of Sorafenib Tablet for Oral Suspension. The trial enrolled 30 healthy male volunteers in Germany and assessed biological availability under controlled, randomized conditions.
Yes, Sorafenib Film-coated is the same as Sorafenib (BAY43-9006) Film-coated tablet. BAY43-9006 is the internal development code for sorafenib, and the film-coated tablet is one of its oral formulations.