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

This study has been completed.

First Received: April 13, 2009 Last Updated: April 14, 2009 History of Changes

Sponsored by:	Sandoz Inc.
Information provided by:	Sandoz Inc.
ClinicalTrials.gov Identifier:	NCT00881231

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
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:

Drug Information available for: Cilostazol

U.S. FDA Resources

Further study details as provided by Sandoz Inc.:

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
1: Experimental Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA)	Drug: Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA)
2: Active Comparator 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

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

Study placed in the following topic categories:

Cilostazol
Vasodilator Agents
Anti-Asthmatic Agents
Pain
Fibrinolytic Agents
Healthy
Cardiovascular Agents

Neuroprotective Agents
Fibrin Modulating Agents
Phosphodiesterase Inhibitors
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Bronchodilator Agents

Additional relevant MeSH terms:

Cilostazol
Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Protective Agents

Neuroprotective Agents
Pharmacologic Actions
Fibrin Modulating Agents
Phosphodiesterase Inhibitors
Autonomic Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on September 04, 2009