Fasted Bioavailability Study of Cilostazol Tablets, 50mg
Condition: Therapeutic Equivalency, Healthy
Intervention: Cilostazol 50 mg Tablets; Cilostazol (Pletal®) 50 mg Tablets
Intervention description: Cilostazol (2 x 50 mg tablets) administered after an overnight fast of at least 10 hours; Cilostazol (Pletal® Tablets, 2 x 50mg) administered after an overnight fast of at least 10 hours.
Intervention MeSH terms: Cilostazol
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate and compare the relative bioavailability of a test
      formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after
      a single oral dose administered under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-55 years of age

          -  Non-smoking

          -  Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive
             measures)

          -  No more than 15% plus or minus 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

          -  Medically healthy on the basis of medical history and physical examination within 30
             days prior to the start of the study

          -  Test results from blood chemistry, hematology, and urinalysis performed within 30days
             prior to the start of the study 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 electrocardiogram (EKG): sinus rhythm with no evidence of AV block or
             ischemic changes

        Exclusion Criteria:

          -  Prescription drug use (excluding hormonal contraceptives) within 14 days prior to drug
             administration, each period

          -  Aspirin ingestion within 7 days prior to drug administration, each period

          -  Use of any over-the-counter preparations, herbal remedies, and/or nutritional
             supplements within 7 days prior to drug administration, each period

          -  Consumption of grapefruit juice or grapefruit-containing products within 72 hours
             prior to drug administration , each period

          -  Consumption of alcohol within 24 hours prior to drug administration, each period

          -  Consumption of caffeine within 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

          -  Subjects with a history or presence of significant organ system (cardiovascular,
             neurological, hepatic, hematopoietic, renal, pulmonary, endocrine, or
             gastrointestinal) disorders, or ongoing infectious diseases

          -  History of hypersensitivity or adverse reactions to cilostazol (Pletal®), or other
             related drugs

          -  Recent (12 month) history or evidence of alcoholism or drug abuse

          -  Positive urine screening of drugs of abuse

          -  Positive results to Human Immunodeficiency Virus (HIV) or Hepatitis B surface Antigen
             (HBsAg) tests

          -  Participation in another clinical trial in the previous 30 days before day 1 of this
             study

          -  Donation of blood in the previous 30 days before day 1 of this study