Trial Outcomes & Findings for Bioavailability of Apixaban Crushed Tablet (NCT NCT02101112)
NCT ID: NCT02101112
Last Updated: 2016-03-03
Results Overview
Maximum observed plasma concentration (Cmax) measured in nanograms per milliliter (ng/mL)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
69 participants
Primary outcome timeframe
Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 and 72 hours post dose
Results posted on
2016-03-03
Participant Flow
69 participants enrolled, 33 participants randomized. 36 participants were enrolled but not randomized. Reasons for non-randomization include 30 participants no longer met study criteria, 4 participants withdrew consent, 2 participants were not needed for the study.
Participant milestones
| Measure |
Treatment C Then Treatment B Then Treatment A
Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
|
Treatment A Then Treatment B Then Treatment C
Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
|
Treatment A Then Treatment C Then Treatment B
Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
|
Treatment B Then Treatment C Then Treatment A
Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
|
Treatment B Then Treatment A Then Treatment C
Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
|
Treatment C Then Treatment A Then Treatment B
Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
5
|
6
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
5
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Treatment C Then Treatment B Then Treatment A
Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
|
Treatment A Then Treatment B Then Treatment C
Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
|
Treatment A Then Treatment C Then Treatment B
Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
|
Treatment B Then Treatment C Then Treatment A
Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
|
Treatment B Then Treatment A Then Treatment C
Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
|
Treatment C Then Treatment A Then Treatment B
Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Bioavailability of Apixaban Crushed Tablet
Baseline characteristics by cohort
| Measure |
Apixaban, 10 mg (Whole Tablets)
n=33 Participants
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
|
|---|---|
|
Age, Continuous
|
32.3 years
STANDARD_DEVIATION 7.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Weight
|
77.40 kilograms
STANDARD_DEVIATION 7.933 • n=5 Participants
|
|
Height
|
172.13 centimeters
STANDARD_DEVIATION 8.322 • n=5 Participants
|
|
Body Mass Index (BMI)
|
26.14 kilograms per meter^2
STANDARD_DEVIATION 2.166 • n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 and 72 hours post dosePopulation: All evaluable pharmacokinetic (PK) participants who were treated with apixaban
Maximum observed plasma concentration (Cmax) measured in nanograms per milliliter (ng/mL)
Outcome measures
| Measure |
Apixaban, 10 mg (Crushed and Suspended in Water)
n=33 Participants
Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
|
Apixaban, 10 mg (Crushed and Mixed With Applesauce)
n=32 Participants
Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
|
Apixaban, 10 mg (Whole Tablets)
n=32 Participants
Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
|
|---|---|---|---|
|
Adjusted Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Apixaban
|
249 ng/mL
Interval 232.0 to 266.0
|
186 ng/mL
Interval 174.0 to 199.0
|
236 ng/mL
Interval 217.0 to 256.0
|
PRIMARY outcome
Timeframe: Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dosePopulation: All evaluable pharmacokinetic (PK) participants who were treated with apixaban
Area Under the Plasma Concentration-time Curve (AUC) From Time of Zero Extrapolated to Infinite Time (INF) \[AUC (INF)\] is measured as nanograms multiplied by hours per milliliter (ng\*h/mL)
Outcome measures
| Measure |
Apixaban, 10 mg (Crushed and Suspended in Water)
n=33 Participants
Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
|
Apixaban, 10 mg (Crushed and Mixed With Applesauce)
n=32 Participants
Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
|
Apixaban, 10 mg (Whole Tablets)
n=32 Participants
Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
|
|---|---|---|---|
|
Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban
|
2528 ng*h/mL
Interval 2375.0 to 2692.0
|
2055 ng*h/mL
Interval 1915.0 to 2206.0
|
2461 ng*h/mL
Interval 2273.0 to 2664.0
|
PRIMARY outcome
Timeframe: Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dosePopulation: All evaluable pharmacokinetic (PK) participants who were treated with apixaban
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Concentration \[AUC (0-T)\] is measured as nanograms multiplied by hours per milliliter (ng\*h/mL)
Outcome measures
| Measure |
Apixaban, 10 mg (Crushed and Suspended in Water)
n=33 Participants
Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
|
Apixaban, 10 mg (Crushed and Mixed With Applesauce)
n=32 Participants
Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
|
Apixaban, 10 mg (Whole Tablets)
n=32 Participants
Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
|
|---|---|---|---|
|
Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban
|
2488 ng*h/mL
Interval 2336.0 to 2651.0
|
2015 ng*h/mL
Interval 1876.0 to 2165.0
|
2423 ng*h/mL
Interval 2238.0 to 2623.0
|
SECONDARY outcome
Timeframe: Randomization to May 2014; approximately 6 weeksPopulation: All randomized and treated participants
Adverse Event (AE) = any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious Adverse Event (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.
Outcome measures
| Measure |
Apixaban, 10 mg (Crushed and Suspended in Water)
n=33 Participants
Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
|
Apixaban, 10 mg (Crushed and Mixed With Applesauce)
n=32 Participants
Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
|
Apixaban, 10 mg (Whole Tablets)
n=32 Participants
Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events, Death, or Discontinuation Due to Adverse Events by Study Completion
Deaths
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events, Death, or Discontinuation Due to Adverse Events by Study Completion
SAEs
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events, Death, or Discontinuation Due to Adverse Events by Study Completion
Drug-related AEs
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events, Death, or Discontinuation Due to Adverse Events by Study Completion
Discontinuation due to AE
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dosePopulation: All evaluable pharmacokinetic (PK) participants who were treated with apixaban
Time of maximum observed plasma concentration (Tmax) measured in hours (h)
Outcome measures
| Measure |
Apixaban, 10 mg (Crushed and Suspended in Water)
n=33 Participants
Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
|
Apixaban, 10 mg (Crushed and Mixed With Applesauce)
n=32 Participants
Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
|
Apixaban, 10 mg (Whole Tablets)
n=32 Participants
Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
|
|---|---|---|---|
|
Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban
|
2.00 hours
Interval 0.583 to 4.0
|
2.00 hours
Interval 1.0 to 4.0
|
2.00 hours
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dosePopulation: All evaluable pharmacokinetic (PK) participants who were treated with apixaban
Terminal plasma half-life (T-HALF) was derived from plasma concentration versus time data. T-HALF was the time required for one half of the total amount of administered drug to be eliminated from the body.
Outcome measures
| Measure |
Apixaban, 10 mg (Crushed and Suspended in Water)
n=33 Participants
Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
|
Apixaban, 10 mg (Crushed and Mixed With Applesauce)
n=32 Participants
Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
|
Apixaban, 10 mg (Whole Tablets)
n=32 Participants
Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
|
|---|---|---|---|
|
Terminal Plasma Half-life (T-HALF) of Apixaban
|
12.2 hours
Standard Deviation 5.19
|
12.5 hours
Standard Deviation 5.05
|
12.4 hours
Standard Deviation 5.39
|
SECONDARY outcome
Timeframe: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dosePopulation: All evaluable pharmacokinetic (PK) participants who were treated with apixaban
Frel is calculated using the treatment ratio of AUC(INF) where the denominator is the AUC(INF) of the reference therapy, 10mg of Apixaban (whole tablet).
Outcome measures
| Measure |
Apixaban, 10 mg (Crushed and Suspended in Water)
n=32 Participants
Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
|
Apixaban, 10 mg (Crushed and Mixed With Applesauce)
Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
|
Apixaban, 10 mg (Whole Tablets)
n=32 Participants
Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
|
|---|---|---|---|
|
Relative Bioavailability (Frel) of Apixaban
|
0.836 ratio
Geometric Coefficient of Variation 20
|
—
|
1.03 ratio
Geometric Coefficient of Variation 24
|
Adverse Events
Apixaban, 10 mg (Whole Tablets)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Apixaban, 10 mg (Crushed and Suspended in Water)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Apixaban, 10 mg (Crushed and Mixed With Applesauce)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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 trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER