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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to assess the bioavailability of Apixaban solution administered through NGT and washed with Dextrose 5% in water (D5W) or infant formula relative to Apixaban solution administered orally in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Apixaban | Experimental | Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via oral syringe |
|
| Arm B: Apixaban | Experimental | Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via nasogastric tube (NGT) immediately followed by 60 mL of D5W via NGT |
|
| Arm C: Apixaban | Experimental | Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via NGT immediately followed by 60 mL of infant formula via NGT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban | Samples of plasma from participants were obtained at the following times: 0 hour (h) and post dose at 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h. Apixaban was assayed using a validated Liquid chromatography tandem mass spectrometry (LC-MS/MS) method during the period of known analyte stability. Maximum observed plasma concentration (Cmax) was measured in nanograms per milliliter (ng/mL). | Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Death | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. |
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Inclusion Criteria:
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel Baltimore Early Phase Clinical Unit | Baltimore | Maryland | 21225 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26188837 | Derived | Song Y, Wang X, Perlstein I, Wang J, Badawy S, Frost C, LaCreta F. Relative Bioavailability of Apixaban Solution or Crushed Tablet Formulations Administered by Mouth or Nasogastric Tube in Healthy Subjects. Clin Ther. 2015 Aug;37(8):1703-12. doi: 10.1016/j.clinthera.2015.05.497. Epub 2015 Jul 15. |
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75 enrolled; 21 randomized; 21 treated. Of the 54 not treated: 47 no longer met study criteria, 1 not needed due to adequate number of participants, 3 withdrew consent, 1 died due to substance abuse, 1 no show, 1 discharged as alternate. Study was 3-treatment crossover administered over 3 periods. ≥4 days washout after doses in Periods 1 and 2.
Participants were admitted to the clinical facility on the evening prior to dosing (Day -1) and remained confined to the clinic for the duration of study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A, Then Treatment B, Then Treatment C | Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe. Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT. Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT. After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3. |
| FG001 | Treatment A, Then Treatment C, Then Treatment B | Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe. Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT. Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT. After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3. |
| FG002 | Treatment B, Then Treatment A, Then Treatment C | Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe. Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT. Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT. After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3. |
| FG003 | Treatment B, Then Treatment C, Then Treatment A | Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe. Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT. Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT. After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3. |
| FG004 | Treatment C, Then Treatment A, Then Treatment B | Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe. Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT. Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT. After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3. |
| FG005 | Treatment C, Then Treatment B, Then Treatment A | Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe. Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT. Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT. After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who received study drug were analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 5mg Apixaban | After a 10 hour fast, participants were randomized to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB or CBA) administered over 3 periods. Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. Treatment A was administered via oral syringe, Treatment B was administered via an NGT followed by 60 mL of D5W via an NGT, and Treatment C was administered via an NGT, followed by 60 mL of infant formula via an NGT. There was at least a 4 day washout before receiving the next scheduled treatment in the next period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Death | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. | All participants who received study drug were analyzed. | Posted | Number | participants | Day 1 to Day 12 |
|
Day 1 to Day 12
All participants who received at least one dose of study drug were analyzed.
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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 | 5mg Apixaban Via Oral Syringe (A) | After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences administered over 3 Periods (ABC, ACB, BAC, BCA, CAB or CBA) and received a single dose of apixaban 5 mg. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3. In Treatment A the single dose of 5 mg apixaban was administered via oral syringe. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
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| ID | Term |
|---|---|
| C522181 | apixaban |
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| Day 1 to Day 12 |
| Median Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban | Samples of plasma from participants were obtained at the following times: 0 hour (h), 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. Maximum observed plasma concentration (Tmax) was measured in hours (h). | Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3 |
| Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration, AUC(0-T), of Apixaban | Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. AUC(0-T) was measured in nanograms*hours per milliliter (ng*h/mL). | Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3 |
| Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time, AUC(INF), of Apixaban | Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. AUC(0-INF) was measured in ng*h/mL. | Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3 |
| Mean Plasma Elimination Half-Life (T-HALF) of Apixaban | Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. T-HALF was measured in hours (h). | Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3 |
| Number of Participants With Clinically Significant Electrocardiogram, Vital Sign, or Physical Examination Findings | 12-lead electrocardiograms (ECGs) and Vital Signs were performed at Screening, and Day 1 of Periods 1, 2 and 3 (pre-dose and prior to NGT placement, if done). Vital signs and ECGs were also performed on Day 4 of Period 3, prior to discharge from the study. Vital signs included body temperature, respiratory rate, seated blood pressure and heart rate. Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes. Participants had physical examinations on Period 1, Day 1 (pre-dose) and Day 4 of Period 3, prior to study discharge. | Screening, Day 1 of Periods, 1, 2, and 3, and Day 4 of Period 3 |
| Number of Participants With Marked Abnormality in Hematology, Chemistry and Urinalysis Laboratory Tests | Participants were required to fast for at least 10 hours prior to the collection of specimens for clinical laboratory tests. Tests were performed at Screening, Day -1, and Day 4 of each period 1 - 3. Leukocyte criteria: Lower limits of normal (LLN), upper limits of normal (ULN), pre-treatment (preRX). Low Leukocytes: if value < 0.9*LLN, or if preRX < LLN then use < 0.85* preRX. High lymphocytes: if value > 7.500 10^3 cells/ µL. Low neutrophils plus bands: if value <= 1.500 10^3 cells/µL. High creatine kinase: if value > 1.5* ULN. Blood in urine: if value >= 2 plus, or if preRX >= 1 plus then use >= 2*preRX. | Screening, Day -1, Day 4 of Periods, 1, 2, and 3 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 5mg Apixaban Via NGT Followed by D5W (B) |
Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT |
| OG002 | 5 mg Apixaban Via NGT Followed by Infant Formula (C) | Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT |
|
|
| Primary | Adjusted Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban | Samples of plasma from participants were obtained at the following times: 0 hour (h) and post dose at 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h. Apixaban was assayed using a validated Liquid chromatography tandem mass spectrometry (LC-MS/MS) method during the period of known analyte stability. Maximum observed plasma concentration (Cmax) was measured in nanograms per milliliter (ng/mL). | All participants who received study drug and had adequate PK profiles were included in the analysis. | Posted | Geometric Mean | 90% Confidence Interval | ng/mL | Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3 |
|
|
|
|
| Secondary | Median Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban | Samples of plasma from participants were obtained at the following times: 0 hour (h), 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. Maximum observed plasma concentration (Tmax) was measured in hours (h). | Posted | Median | Full Range | h | Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3 |
|
|
|
| Secondary | Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration, AUC(0-T), of Apixaban | Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. AUC(0-T) was measured in nanograms*hours per milliliter (ng*h/mL). | All participants who received study drug and had adequate PK profiles were included in the analysis. | Posted | Geometric Mean | 90% Confidence Interval | ng*h/mL | Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3 |
|
|
|
|
| Secondary | Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time, AUC(INF), of Apixaban | Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. AUC(0-INF) was measured in ng*h/mL. | All participants who received study drug and had adequate PK profiles were included in the analysis. | Posted | Geometric Mean | 90% Confidence Interval | ng*h/mL | Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3 |
|
|
|
|
| Secondary | Mean Plasma Elimination Half-Life (T-HALF) of Apixaban | Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. T-HALF was measured in hours (h). | All participants who received study drug and had adequate PK profiles were included in the analysis. | Posted | Mean | Standard Deviation | h | Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Electrocardiogram, Vital Sign, or Physical Examination Findings | 12-lead electrocardiograms (ECGs) and Vital Signs were performed at Screening, and Day 1 of Periods 1, 2 and 3 (pre-dose and prior to NGT placement, if done). Vital signs and ECGs were also performed on Day 4 of Period 3, prior to discharge from the study. Vital signs included body temperature, respiratory rate, seated blood pressure and heart rate. Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes. Participants had physical examinations on Period 1, Day 1 (pre-dose) and Day 4 of Period 3, prior to study discharge. | All participants who received study drug were analyzed. | Posted | Number | participants | Screening, Day 1 of Periods, 1, 2, and 3, and Day 4 of Period 3 |
|
|
|
| Secondary | Number of Participants With Marked Abnormality in Hematology, Chemistry and Urinalysis Laboratory Tests | Participants were required to fast for at least 10 hours prior to the collection of specimens for clinical laboratory tests. Tests were performed at Screening, Day -1, and Day 4 of each period 1 - 3. Leukocyte criteria: Lower limits of normal (LLN), upper limits of normal (ULN), pre-treatment (preRX). Low Leukocytes: if value < 0.9*LLN, or if preRX < LLN then use < 0.85* preRX. High lymphocytes: if value > 7.500 10^3 cells/ µL. Low neutrophils plus bands: if value <= 1.500 10^3 cells/µL. High creatine kinase: if value > 1.5* ULN. Blood in urine: if value >= 2 plus, or if preRX >= 1 plus then use >= 2*preRX. | Participants who received study drug were analyzed. | Posted | Number | participants | Screening, Day -1, Day 4 of Periods, 1, 2, and 3 |
|
|
|
| 0 |
| 21 |
| 2 |
| 21 |
| EG001 | 5mg Apixaban Via NGT Followed by D5W (B) | In Treatment B the single dose of 5 mg apixaban was administered via nasogastric tube (NGT) followed by 60 mL of dextrose, water (D5W) via the NGT. | 0 | 21 | 4 | 21 |
| EG002 | 5 mg Apixaban Via NGT Followed by Infant Formula (C) | In Treatment C, the single dose of 5 mg apixaban was administered via NGT, followed by 60 mL of infant formula via the NGT. | 0 | 21 | 3 | 21 |
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Eyelid Oedema | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (14.1) | Non-systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trials primary publication.
| Ratio of adjusted geometric means |
| 0.805 |
| 2-Sided |
| 90 |
| 0.749 |
| 0.865 |
| No |
| Superiority or Other |
| Ratio of adjusted geometric means |
| 0.919 |
| 2-Sided |
| 90 |
| 0.896 |
| 0.942 |
| No |
| Superiority or Other |
| Ratio of adjusted geometric means |
| 0.922 |
| 2-Sided |
| 90 |
| 0.899 |
| 0.947 |
| No |
| Superiority or Other |
| Title | Measurements |
|---|---|
|
| Physical Examination |
|
| Title | Measurements |
|---|---|
|
| High Creatine Kinase |
|
| Blood in Urine |
|