Bioequivalency Study of 50 mg Cilostazol Tablets Under Fasting Conditions

This study has been completed.

Sponsored by:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00602407

Purpose

The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 50 mg, to PLETAL® Tablets, 50 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, crossover design.

Condition	Intervention
Intermittent Claudication	Drug: Cilostazol

Drug Information available for: Cilostazol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Single Dose, Randomized, Two-Period, Two-Treatment, Crossover Bioequivalency Study of Cilostazol 50 mg Tablets Under Fasting Conditions

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

Bioequivalence [ Time Frame: Baseline, Two period, Seven day washout ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	February 2004
Study Completion Date:	March 2004
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

Positive test for HIV, Hepatitis B, or Hepatitis C.
Treatment with known enzyme altering drugs.
History of allergic or adverse response to Cilostazol or any comparable or similar product.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602407

Locations

United States, Texas
CEDRA Clinical Research, LLC
Austin, Texas, United States, 78759

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

Daniel V Freeland, DO

CEDRA Clinical Research, LLC

More Information

Responsible Party:	Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs )
Study ID Numbers:	CILO-05
Study First Received:	January 15, 2008
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00602407
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Arterial Occlusive Diseases
Cilostazol
Signs and Symptoms

Vascular Diseases
Intermittent Claudication
Arteriosclerosis

Additional relevant MeSH terms:

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
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009