Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

To Demonstrate the Relative Bioavailability of Cilostazol 50 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00881231
First received: April 13, 2009
Last updated: April 14, 2009
Last verified: April 2009

April 13, 2009
April 14, 2009
January 2004
February 2004   (final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00881231 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
To Demonstrate the Relative Bioavailability of Cilostazol 50 mg Tablets Under Fasting Conditions
Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Eon and Otsuka (Pletal) 50 mg Cilostazol Tablets In Healthy Adults Volunteers Under Fasting Conditions

To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting conditions.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
  • Drug: Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA)
  • Drug: Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)
  • Experimental: 1
    Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA)
    Intervention: Drug: Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA)
  • Active Comparator: 2
    Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)
    Intervention: Drug: Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
February 2004
February 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.
Both
19 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00881231
AA17524
Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz Inc.
Not Provided
Principal Investigator: Gaetano Morelli, M.D. MDS Pharma Services
Sandoz
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP