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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002083-16 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve From Zero to Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) of Sorafenib in Plasma (AUC[0-tlast]) After Single Oral Dose | 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. | Pre-dose (0 hour) to 120 hours post-dose |
| Maximum Observed Drug Concentration After Single Dose Administration (Cmax) of Sorafenib in Plasma | 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. | Pre-dose (0 hour) to 120 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Drug Concentration After Single Dose Administration Divided by Dose (Cmax/D) of Sorafenib in Plasma | Maximum observed drug concentration after single dose administration divided by dose of sorafenib in plasma was measured. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | Pre-dose (0 hour) to 120 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
Medical and surgical history:
Electrocardiogram (ECG), blood pressure, heart rate:
Laboratory examination:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | 13353 | Germany |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| 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. |
|
| 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. |
|
| Area Under the Concentration Versus Time Curve From Zero to Infinity After Single Dose (AUC) of Sorafenib in Plasma | Area under the concentration versus time curve from zero to infinity after single dose of sorafenib in plasma was measured. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | Pre-dose (0 hour) to 120 hours post-dose |
| Area Under the Concentration Versus Time Curve From Zero to Infinity After Single Dose Divided by Dose (AUC/D) of Sorafenib in Plasma | Area under the concentration versus time curve from zero to infinity after single dose divided by dose of sorafenib in plasma. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | Pre-dose (0 hour) to 120 hours post-dose |
| Area Under the Concentration Versus Time Curve From Zero to Last Data Point Divided by Dose (AUC[0-tlast]/D) of Sorafenib in Plasma | Area under the concentration versus time curve from zero to last data point divided by dose of sorafenib in plasma was measured. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | Pre-dose (0 hour) to 120 hours post-dose |
| Total Body Clearance of Sorafenib Calculated After Extravascular Administration (CL/F) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | Pre-dose (0 hour) to 120 hours post-dose |
| Time to Reach Maximum Concentration (tmax) of Sorafenib in Plasma | Time to reach maximum concentration of sorafenib in plasma. | Pre-dose (0 hour) to 120 hours post-dose |
| Half-life Associated With the Terminal Slope (t1/2) of Sorafenib in Plasma | Half-life associated with the terminal slope of sorafenib in plasma. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | Pre-dose (0 hour) to 120 hours post-dose |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. AEs that started or worsened after first administration of study medication up to 30 days after end of treatment with study medication were considered to be treatment-emergent (TE). A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly and another medical important serious event as judged by investigator. SAEs that started or worsened after study drug treatment were recorded as TESAEs. | From start of study treatment up to 30 days after the last sorafenib dose administration |
| Number of Subjects With Various Acceptance Regarding the Taste and Palatability of the Tablet Formulations | For each administration of sorafenib, subjects completed a questionnaire regarding the taste and palatability of the tablets for oral suspension or marketed tablets within 5 to 10 min after administration. Results from the questionnaire regarding the taste of tablet, aftertaste and overall impression of the two different tablet formulations were analysed. CD= Completely disagree; SD= Somewhat disagree; Ne= Neutral; SA= Somewhat agree; CA= Completely agree; Un= Unknown. | Within 5 to 10 min of each administration of sorafenib |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |