Trial Outcomes & Findings for Fasted Bioavailability Study of Cilostazol Tablets, 100 mg (NCT NCT00684762)
NCT ID: NCT00684762
Last Updated: 2009-12-22
Results Overview
The maximum or peak concentration that cilostazol (test and reference product) reaches in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.
Results posted on
2009-12-22
Participant Flow
Participant milestones
| Measure |
Cilostazol 100 mg Tablets Then Pletal® 100 mg Tablets
On the morning of Day 1 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours.
|
Pletal® 100 mg Tablets Then Cilostazol 100 mg Tablets
On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
|
|---|---|---|
|
First Intervention
STARTED
|
16
|
16
|
|
First Intervention
COMPLETED
|
16
|
16
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period of 7 Days
STARTED
|
16
|
16
|
|
Washout Period of 7 Days
COMPLETED
|
14
|
14
|
|
Washout Period of 7 Days
NOT COMPLETED
|
2
|
2
|
|
Second Intervention
STARTED
|
14
|
14
|
|
Second Intervention
COMPLETED
|
14
|
14
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cilostazol 100 mg Tablets Then Pletal® 100 mg Tablets
On the morning of Day 1 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours.
|
Pletal® 100 mg Tablets Then Cilostazol 100 mg Tablets
On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Washout Period of 7 Days
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Fasted Bioavailability Study of Cilostazol Tablets, 100 mg
Baseline characteristics by cohort
| Measure |
Cilostazol 100 mg Tablets and Pletal® 100 mg Tablets
n=32 Participants
All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
36.09 years
STANDARD_DEVIATION 11.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.Population: Plasma concentration data for 28 of the 32 enrolled participants were used in the statistical analysis. Four subjects did not complete the study and none of their collected data was used.
The maximum or peak concentration that cilostazol (test and reference product) reaches in the plasma.
Outcome measures
| Measure |
Cilostazol 100 mg Tablets
n=28 Participants
On the morning of Day 1 subjects received one tablet of either the test formulation, cilostazol 100mg, or the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
|
Pletal® 100 mg Tablets
n=28 Participants
On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
484.895 ng/mL
Standard Deviation 205.181
|
472.689 ng/mL
Standard Deviation 140.843
|
PRIMARY outcome
Timeframe: serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.Population: Plasma concentration data for 28 of the 32 enrolled participants were used in the statistical analysis. Four subjects did not complete the study and none of their collected data was used.
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable cilostazol (test and reference) concentration (t), as calculated by the linear trapezoidal rule.
Outcome measures
| Measure |
Cilostazol 100 mg Tablets
n=28 Participants
On the morning of Day 1 subjects received one tablet of either the test formulation, cilostazol 100mg, or the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
|
Pletal® 100 mg Tablets
n=28 Participants
On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
6,518.90 ng-hr/mL
Standard Deviation 1,600.14
|
6,711.57 ng-hr/mL
Standard Deviation 1,895.25
|
PRIMARY outcome
Timeframe: serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.Population: Plasma concentration data for 26 of the 32 enrolled participants were used in the statistical analysis. Four subjects did not complete the study and none of their collected data was used. Additionally, two subjects had data values that were not used in this analysis.
The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable cilostazol (reference and test) plasma concentration to the elimination rate constant.
Outcome measures
| Measure |
Cilostazol 100 mg Tablets
n=26 Participants
On the morning of Day 1 subjects received one tablet of either the test formulation, cilostazol 100mg, or the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
|
Pletal® 100 mg Tablets
n=26 Participants
On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
|
7,224.99 ng-hr/mL
Standard Deviation 1,786.61
|
7,650.45 ng-hr/mL
Standard Deviation 2,294.39
|
Adverse Events
Cilostazol 100 mg Tablets
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Pletal® 100 mg Tablets
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cilostazol 100 mg Tablets
n=30 participants at risk
All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
|
Pletal® 100 mg Tablets
n=30 participants at risk
All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Nervous system disorders
Headache
|
20.0%
6/30 • Number of events 6
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
20.0%
6/30 • Number of events 6
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
|
Injury, poisoning and procedural complications
Pain
|
0.00%
0/30
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
3.3%
1/30 • Number of events 1
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
|
Investigations
Eosinophilia
|
0.00%
0/30
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
3.3%
1/30 • Number of events 1
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
|
Blood and lymphatic system disorders
Lymphadeno
|
3.3%
1/30 • Number of events 1
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
0.00%
0/30
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.3%
1/30 • Number of events 1
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
0.00%
0/30
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
|
Metabolism and nutrition disorders
LDH increased
|
3.3%
1/30 • Number of events 1
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
0.00%
0/30
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
|
Metabolism and nutrition disorders
SGOT increased
|
3.3%
1/30 • Number of events 1
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
0.00%
0/30
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
|
Injury, poisoning and procedural complications
Paresthesia
|
3.3%
1/30 • Number of events 1
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
0.00%
0/30
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/30
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
3.3%
1/30 • Number of events 1
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
|
Renal and urinary disorders
Urine abnormal
|
0.00%
0/30
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
10.0%
3/30 • Number of events 3
32 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 30 subjects were administered cilostazol 100 mg tablets and 30 subjects were administered Pletal® 100 mg tablets.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60