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Cilostazol 50 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00839930
First received: February 6, 2009
Last updated: September 1, 2009
Last verified: September 2009
History of Changes
Results First Received: June 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Interventions: Drug: Cilostazol 50 mg Tablets
Drug: Pletal®

  Participant Flow
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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
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Reporting Groups
  Description
Cilostazol (Test) First Cilostazol 50 mg Tablets (test)dosed in first period followed by Pletal® 50 mg Tablets (reference) dosed in second period
Pletal® (Reference) First Pletal® 50 mg Tablets (reference) dosed in first period followed by Cilostazol 50 mg Tablets (test) dosed in second period

Participant Flow for 3 periods

 Period 1:   First Intervention
    Cilostazol (Test) First     Pletal® (Reference) First  
STARTED     15     15  
COMPLETED     15     15  
NOT COMPLETED     0     0  

Period 2:   Washout: 7 Days
    Cilostazol (Test) First     Pletal® (Reference) First  
STARTED     15     15  
COMPLETED     15     15  
NOT COMPLETED     0     0  

Period 3:   Second Intervention
    Cilostazol (Test) First     Pletal® (Reference) First  
STARTED     15     15  
COMPLETED     15     15  
NOT COMPLETED     0     0  



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Cmax - Maximum Observed Concentration   [ Time Frame: Blood samples collected over 72 hour period ]
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2.  Primary:   AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)   [ Time Frame: Blood samples collected over 72 hour period ]
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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 72 hour period ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


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


No publications provided


ClinicalTrials.gov Identifier: NCT00839930     History of Changes
Other Study ID Numbers: R04-099
Study First Received: February 6, 2009
Results First Received: June 18, 2009
Last Updated: September 1, 2009
Health Authority: United States: Institutional Review Board