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
  Purpose

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


Condition Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: January 2004
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00881231

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

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00881231     History of Changes
Other Study ID Numbers: AA17524
Study First Received: April 13, 2009
Last Updated: April 14, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 21, 2014