Trial · NCT00684762
Fasted Bioavailability Study of Cilostazol Tablets, 100 mg
NCT00684762, Phase 1, Completed, Mutual Pharmaceutical Company, Inc.; results first posted 2009-12-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fasted Bioavailability Study of Cilostazol Tablets, 100 mg. Trials, record NCT00684762. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00684762
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fasted Bioavailability Study of Cilostazol Tablets, 100 mg
- NCT number
- NCT00684762
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 32 participants, actual
- Lead sponsor
- Mutual Pharmaceutical Company, Inc.
- Conditions
- Therapeutic Equivalency
- Interventions
- Cilostazol 100 mg Tablets, Cilostazol (Pletal®) 100 mg Tablets
- First posted
- 2008-05-28
- Last updated
- 2009-12-22
- Results first posted
- 2009-12-22
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) | 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. | The maximum or peak concentration that cilostazol (test and reference product) reaches in the plasma. |
| Primary | Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] | 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. | 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. |
| Primary | Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] | 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. | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Plasma Concentration (Cmax) | 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. | 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. | ng/mL | MEAN |
| PRIMARY | Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] | 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. | 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. | ng-hr/mL | MEAN |
| PRIMARY | Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] | 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. | 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. | ng-hr/mL | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Plasma Concentration (Cmax) | Cilostazol 100 mg Tablets | 484.895 | Standard Deviation 205.181 | ng/mL | |
| Maximum Plasma Concentration (Cmax) | Pletal® 100 mg Tablets | 472.689 | Standard Deviation 140.843 | ng/mL | |
| Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] | Cilostazol 100 mg Tablets | 6,518.90 | Standard Deviation 1,600.14 | ng-hr/mL | |
| Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] | Pletal® 100 mg Tablets | 6,711.57 | Standard Deviation 1,895.25 | ng-hr/mL | |
| Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] | Cilostazol 100 mg Tablets | 7,224.99 | Standard Deviation 1,786.61 | ng-hr/mL | |
| Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] | Pletal® 100 mg Tablets | 7,650.45 | Standard Deviation 2,294.39 | ng-hr/mL |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Cilostazol 100 mg Tablets Then Pletal® 100 mg Tablets | 16 | |
| First Intervention | STARTED | Pletal® 100 mg Tablets Then Cilostazol 100 mg Tablets | 16 | |
| First Intervention | COMPLETED | Cilostazol 100 mg Tablets Then Pletal® 100 mg Tablets | 16 | |
| First Intervention | COMPLETED | Pletal® 100 mg Tablets Then Cilostazol 100 mg Tablets | 16 | |
| First Intervention | NOT COMPLETED | Cilostazol 100 mg Tablets Then Pletal® 100 mg Tablets | 0 | |
| First Intervention | NOT COMPLETED | Pletal® 100 mg Tablets Then Cilostazol 100 mg Tablets | 0 | |
| Washout Period of 7 Days | STARTED | Cilostazol 100 mg Tablets Then Pletal® 100 mg Tablets | 16 | |
| Washout Period of 7 Days | STARTED | Pletal® 100 mg Tablets Then Cilostazol 100 mg Tablets | 16 | |
| Washout Period of 7 Days | COMPLETED | Cilostazol 100 mg Tablets Then Pletal® 100 mg Tablets | 14 | |
| Washout Period of 7 Days | COMPLETED | Pletal® 100 mg Tablets Then Cilostazol 100 mg Tablets | 14 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Cilostazol 100 mg Tablets | 6 | 30 | 6 |
| other | Headache | Nervous system disorders | Pletal® 100 mg Tablets | 6 | 30 | 6 |
| other | Pain | Injury, poisoning and procedural complications | Cilostazol 100 mg Tablets | 0 | 30 | 0 |
| other | Pain | Injury, poisoning and procedural complications | Pletal® 100 mg Tablets | 1 | 30 | 1 |
| other | Eosinophilia | Investigations | Cilostazol 100 mg Tablets | 0 | 30 | 0 |
| other | Eosinophilia | Investigations | Pletal® 100 mg Tablets | 1 | 30 | 1 |
| other | Lymphadeno | Blood and lymphatic system disorders | Cilostazol 100 mg Tablets | 1 | 30 | 1 |
| other | Lymphadeno | Blood and lymphatic system disorders | Pletal® 100 mg Tablets | 0 | 30 | 0 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Cilostazol 100 mg Tablets | 1 | 30 | 1 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Pletal® 100 mg Tablets | 0 | 30 | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cilostazol 100 mg Tablets | ||
| Total, all-cause mortality | Pletal® 100 mg Tablets | ||
| Total, other adverse events | Cilostazol 100 mg Tablets | 11 | 30 |
| Total, other adverse events | Pletal® 100 mg Tablets | 12 | 30 |
| Total, serious adverse events | Cilostazol 100 mg Tablets | 0 | 30 |
| Total, serious adverse events | Pletal® 100 mg Tablets | 0 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cilostazol 100 mg Tablets vs Pletal® 100 mg Tablets: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00684762
GET https://conductscience.org/api/trials/v1/NCT00684762/registered