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

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ClinicalTrials.gov Identifier: NCT00881231
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

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

Condition or disease Intervention/treatment Phase
Pain Drug: Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA) Drug: Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2004
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Cilostazol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA)
Drug: Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA)
Active Comparator: 2
Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)
Drug: Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)



Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 21 days ]


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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881231


Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: Gaetano Morelli, M.D. MDS Pharma Services

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00881231     History of Changes
Other Study ID Numbers: AA17524
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: April 2009

Additional relevant MeSH terms:
Cilostazol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors