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Fasted Bioavailability Study of Cilostazol Tablets, 100 mg
This study has been completed.
Sponsored by: Mutual Pharmaceutical Company, Inc.
Information provided by: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00684762
  Purpose

The objective of this study was to compare the plasma levels of cilostazol produced after administration of the test formulation with those produced after administration of the marketed reference product, under fasting conditions


Condition Intervention Phase
Therapeutic Equivalency
Drug: Cilostazol
Phase I

Drug Information available for: Cilostazol
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title: A Comparative Bioavailability Study of Cilostazol Tablets, 100mg Under Fasting Conditions

Further study details as provided by Mutual Pharmaceutical Company, Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: March 2004
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
one test product tablet was administered at 0 hour with 240 mL of room temperature water
Drug: Cilostazol
Tablet, 100 mg
B: Active Comparator
one tablet of the reference listed drug, Pletal, was administered at 0 hour with 240 mL of room temperature water
Drug: Cilostazol
Tablet, 100 mg

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females, healthy, 18-55 years of age
  • No more than plus or minus 15% from ideal weight for subject's height and elbow breadth as defined by the Metropolitan Life Insurance Company Statistical Bulletin. Extrapolations, if required, to be conducted according to BASi Standard Operating Procedures
  • General good health as determined by a medical history and physical examination within 30 days prior to the start of the study
  • Without a history of clinically significant organ-system(cardiovascular, neurological, hepatic, hematopoietic, renal, pulmonary,endocrine, or gastrointestinal) disorders, or ongoing infectious diseases
  • Without a history of hypersensitivity or adverse reactions to cilostazol (Pletal), or other related drugs
  • Without a history of alcohol abuse or drug addiction requiring treatment within the last 12 months
  • Blood chemistry, hematology, and urinalysis tests performed within 30 days prior to the start of the study. Test results had to be within clinically acceptable limits
  • At screening, subjects must have blood pressure and pulse rate within the following ranges: Systolic blood pressure 90-140mmHg; Diastolic blood pressure 50-90mmHg; Pulse 45-100 bpm
  • An acceptable ECG (electrocardiogram): sinus rhythm with no evidence of AV block or ischemic changes
  • Subjects must be non-smokers

Exclusion Criteria:

  • No prescription drugs (excluding hormonal contraceptives) within 14 days prior to drug administration, each period
  • No aspirin ingestion within 7 days prior to drug administration, each period
  • Subjects had to refrain from taking any OTC preparations, herbal remedies, and/or nutritional supplements within 7 days prior to drug administration, each period
  • No grapefruit juice or grapefruit-containing products for at least 72 hours prior to drug administration , each period
  • No alcohol consumption for at least 24 hours prior to drug administration, each period
  • No caffeine consumption for at least 10 hours prior to drug administration, each period
  • Female subjects must not be pregnant or nursing; and must be surgically sterile; one year post-menopausal; or on hormonal contraceptive agent(s), a diaphragm or condom with spermicidal foam or jelly, or IUD for at least three months prior to drug administration and agree to use the same method of contraception for at least 1 month after the last drug administration
  • Negative serum pregnancy test at screening and negative urine pregnancy test prior to drug administration, each period
  • Negative HIV, hepatitis B surface antigen, and urine screen for drugs of abuse within 30 days prior to the start of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684762

Sponsors and Collaborators
Mutual Pharmaceutical Company, Inc.
Investigators
Principal Investigator: Dilip K Guha-Ray, M.D. BASi Baltimore Clinical Research Unit
  More Information

Recalls, Market Withdrawals and Safety Alerts  This link exits the ClinicalTrials.gov site
Daily Med - Posting of Recently Submitted Labeling to the FDA  This link exits the ClinicalTrials.gov site
URL Pharma Generic Division  This link exits the ClinicalTrials.gov site

Responsible Party: Mutual Pharmaceutical Company, Inc. ( Kristin Arnold, Vice President R&D )
Study ID Numbers: 11788
Study First Received: May 24, 2008
Last Updated: May 24, 2008
ClinicalTrials.gov Identifier: NCT00684762  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Cilostazol

Additional relevant MeSH terms:
Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
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 January 16, 2009