We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Cilostazol 100 mg Tablet Formulations Under Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00838630
Recruitment Status : Completed
First Posted : February 6, 2009
Results First Posted : July 21, 2009
Last Update Posted : September 11, 2009
Sponsor:
Information provided by:

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition: Healthy
Interventions: Drug: Cilostazol 100 mg tablets
Drug: Pletal® 100 mg tablets

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cilostazol (Test) First Cilostazol 100 mg Tablets (test) dosed in first period followed by Pletal® 100 mg Tablets (reference) dosed in second period.
Pletal® (Reference) First Pletal® 100 mg Tablets (reference) dosed in first period followed by Cilostazol 100 mg Tablets (test) dosed in second period

Participant Flow for 3 periods

Period 1:   First Intervention
    Cilostazol (Test) First   Pletal® (Reference) First
STARTED   18   18 
COMPLETED   17   18 
NOT COMPLETED   1   0 
Adverse Event                1                0 

Period 2:   Washout: 7 Days
    Cilostazol (Test) First   Pletal® (Reference) First
STARTED   17   18 
COMPLETED   16   18 
NOT COMPLETED   1   0 
Protocol Violation                1                0 

Period 3:   Second Intervention
    Cilostazol (Test) First   Pletal® (Reference) First
STARTED   16   18 
COMPLETED   16   18 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cilostazol (Test) First Cilostazol 100 mg Tablets (test) dosed in first period followed by Pletal® 100 mg Tablets (reference) dosed in second period.
Pletal® (Reference) First Pletal® 100 mg Tablets (reference) dosed in first period followed by Cilostazol 100 mg Tablets (test) dosed in second period
Total Total of all reporting groups

Baseline Measures
   Cilostazol (Test) First   Pletal® (Reference) First   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   18   36 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   18   18   36 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   2   3   5 
Male   16   15   31 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   17   15   32 
Black   1   3   4 
Region of Enrollment 
[Units: Participants]
     
United States   18   18   36 


  Outcome Measures

1.  Primary:   Cmax - Maximum Observed Concentration   [ Time Frame: Blood samples collected over 96 hour period ]

2.  Primary:   AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)   [ Time Frame: Blood samples collected over 96 hour period ]

3.  Primary:   AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration   [ Time Frame: Blood samples collected over 96 hour period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Manager, Biopharmaceutics
Organization: Teva Pharmaceuticals USA
phone: 1-866-384-5525
e-mail: clinicaltrialqueries@tevausa.com



ClinicalTrials.gov Identifier: NCT00838630     History of Changes
Other Study ID Numbers: 03261
First Submitted: February 5, 2009
First Posted: February 6, 2009
Results First Submitted: June 18, 2009
Results First Posted: July 21, 2009
Last Update Posted: September 11, 2009