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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000500-38 | EudraCT Number |
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This study is intended to estimate the relative bioavailability of a single 500 mg dose of bosutinib when administered as capsule contents mixed with applesauce or yogurt to intact capsules under fed condition in adult healthy participants. The comparisons will be performed using the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. Statistical analyses will be performed comparing these parameters calculated after administration of a single 500 mg dose with the intact capsule formulation (100 mg x 5) as the Reference treatment and the capsule contents mixed with applesauce or yogurt (100 mg x 5) as the Test treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bosutinib capsule contents mixed with applesauce | Experimental | Bosutinib capsule contents mixed with applesauce to healthy participants |
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| Bosutinib capsule contents mixed with yogurt | Experimental | Bosutinib capsule contents mixed with yogurt to healthy participants |
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| Bosutinib intact capsules | Active Comparator | Bosutinib intact capsules to healthy participants |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosutinib capsule | Drug | 500 mg dose of bosutinib capsule contents mixed with applesauce |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for Bosutinib | AUCinf was calculated as [AUClast+(Clast*/kel)], where AUClast is the area under the plasma concentration-time profile from time 0 to the time of the Clast, Clast is the last quantifiable concentration, Clast* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The geometric coefficient of variation was reported as percentage. | Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose |
| Maximum Observed Plasma Concentration (Cmax) for Bosutinib | Cmax was the maximum observed plasma concentration. The geometric coefficient of variation was reported as percentage. | Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Bosutinib | AUClast was the area under the concentration-time curve from time 0 to the time of the last quantifiable concentration. Linear/Log trapezoidal method was used to determine AUClast. The geometric coefficient of variation was reported as percentage. | Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose |
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Inclusion Criteria:
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease.
Any condition possibly affecting drug absorption.
Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 18 participants were assigned to the study intervention, 16 of whom received all the 3 randomized treatment by sequence and completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: Treatment C=>Treatment A =>Treatment B | Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 22, 2021 | Jan 20, 2023 |
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A Phase 1, open-label, randomized, single dose, 3-period, 6-sequence, crossover study in healthy participants
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| Bosutinib capsule | Drug | 500 mg dose of bosutinib capsule contents mixed with yogurt |
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| Bosutinib capsule | Drug | 500 mg dose of intact bosutinib capsules |
|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for Bosutinib | Tmax was the time to reach maximum observed plasma concentration and was observed directly from data as time of the first occurrence. | Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose |
| Apparent Clearance After Oral Dose (CL/F) for Bosutinib | CL/F was the apparent clearance after oral dose and was determined as dose/AUCinf. The geometric coefficient of variation was reported as percentage. | Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose |
| Apparent Volume of Distribution After Oral Dose (Vz/F) for Bosutinib | Vz/F was the apparent volume of distribution after oral dose. It was determined as dose/(AUCinf × kel), where kel was the terminal elimination phase rate constant calculated by a linear regression of the log-linear concentration time curve. The geometric coefficient of variation was reported as percentage. | Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose |
| Terminal Phase Half-life (t½ ) for Bosutinib | t½ was the terminal elimination plasma half-life. It was determined as Loge(2)/kel, where kel was the terminal elimination phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose |
| Number of Participants With Laboratory Abnormalities | Laboratory tests included hematology tests, chemistry tests, and urinalysis tests. | Post first dose and up to Day 7 in Period 3, or at early termination/discontinuation. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Severe Adverse Events (AEs), and Serious Adverse Events (SAEs) | TEAEs are those with initial onset or that worsen in severity after the first dose of the study medication. All AEs in the table below were TEAEs. An SAE is any untoward medical occurrence at any dose that: results in death; is life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event. Severe AEs were defined as AEs that interfered significantly with participant's usual function. Both SAEs and severe AEs were according to the investigator's assessment. | Up to 12 weeks |
| FG001 | Sequence 2: Treatment B=>Treatment C =>Treatment A | Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses. |
| FG002 | Sequence 3: Treatment A=>Treatment B =>Treatment C | Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses. |
| FG003 | Sequence 4: Treatment B=>Treatment A =>Treatment C | Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses. |
| FG004 | Sequence 5: Treatment A=>Treatment C =>Treatment B | Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses. |
| FG005 | Sequence 6: Treatment C=>Treatment B =>Treatment A | Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses. |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| Period 3 |
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All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for Bosutinib | AUCinf was calculated as [AUClast+(Clast*/kel)], where AUClast is the area under the plasma concentration-time profile from time 0 to the time of the Clast, Clast is the last quantifiable concentration, Clast* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The geometric coefficient of variation was reported as percentage. | Total number of participants received treatment and had bosutinib pharmacokinetic (PK) parameter contributing to the summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram•hour per milliliter (ng•hr/mL) | Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Maximum Observed Plasma Concentration (Cmax) for Bosutinib | Cmax was the maximum observed plasma concentration. The geometric coefficient of variation was reported as percentage. | Total number of participants received treatment and had bosutinib PK parameter contributing to the summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Bosutinib | AUClast was the area under the concentration-time curve from time 0 to the time of the last quantifiable concentration. Linear/Log trapezoidal method was used to determine AUClast. The geometric coefficient of variation was reported as percentage. | Total number of participants received treatment and had bosutinib PK parameter contributing to the summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram•hour per milliliter (ng•hr/mL) | Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) for Bosutinib | Tmax was the time to reach maximum observed plasma concentration and was observed directly from data as time of the first occurrence. | Total number of participants received treatment and had bosutinib PK parameter contributing to the summary statistics. | Posted | Median | Full Range | hour | Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose |
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| Secondary | Apparent Clearance After Oral Dose (CL/F) for Bosutinib | CL/F was the apparent clearance after oral dose and was determined as dose/AUCinf. The geometric coefficient of variation was reported as percentage. | Total number of participants received treatment and had bosutinib PK parameter contributing to the summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter/hour | Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose |
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| Secondary | Apparent Volume of Distribution After Oral Dose (Vz/F) for Bosutinib | Vz/F was the apparent volume of distribution after oral dose. It was determined as dose/(AUCinf × kel), where kel was the terminal elimination phase rate constant calculated by a linear regression of the log-linear concentration time curve. The geometric coefficient of variation was reported as percentage. | Total number of participants received treatment and had bosutinib PK parameter contributing to the summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter | Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose |
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| Secondary | Terminal Phase Half-life (t½ ) for Bosutinib | t½ was the terminal elimination plasma half-life. It was determined as Loge(2)/kel, where kel was the terminal elimination phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | Total number of participants received treatment and had bosutinib PK parameter contributing to the summary statistics. | Posted | Mean | Standard Deviation | hour | Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose |
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| Secondary | Number of Participants With Laboratory Abnormalities | Laboratory tests included hematology tests, chemistry tests, and urinalysis tests. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Post first dose and up to Day 7 in Period 3, or at early termination/discontinuation. |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Severe Adverse Events (AEs), and Serious Adverse Events (SAEs) | TEAEs are those with initial onset or that worsen in severity after the first dose of the study medication. All AEs in the table below were TEAEs. An SAE is any untoward medical occurrence at any dose that: results in death; is life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event. Severe AEs were defined as AEs that interfered significantly with participant's usual function. Both SAEs and severe AEs were according to the investigator's assessment. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | No | Up to 12 weeks |
|
Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bosutinib 500 mg Capsule Contents + Applesauce 45 mL | Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. | 0 | 16 | 0 | 16 | 11 | 16 |
| EG001 | Bosutinib 500 mg Capsule Contents + Yogurt 45 mL | Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. | 0 | 17 | 0 | 17 | 14 | 17 |
| EG002 | Bosutinib 500 mg Intact Capsule | Bosutinib 500 mg single dose was administered as intact capsules. | 0 | 18 | 0 | 18 | 15 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Anorectal discomfort | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Chills | General disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Feeling of body temperature change | General disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Vessel puncture site reaction | General disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Upper respiratory tract irritation | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA v24.1 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 26, 2021 | Jan 20, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| C471992 | bosutinib |
Not provided
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| 36-45 years |
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| Older than 45 years |
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| Natural logarithm-transformed bosutinib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + yogurt 45 mL [Test] - Bosutinib 500 mg intact capsule [Reference]) and corresponding 90% CIs were obtained from the model. | ratio of adjusted geometric means | 101.93 | 2-Sided | 90 | 93.97 | 110.56 | Equivalence | The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages. |
| Counts |
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| Units | Counts |
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| Participants |
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| Participants |
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| Participants |
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| OG002 |
| Bosutinib 500 mg Intact Capsule |
Bosutinib 500 mg single dose was administered as intact capsules. |
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