Cilostazol 100 mg Tablet Formulations Under Fasting Conditions
Condition: Healthy
Intervention: Cilostazol 100 mg tablets; Pletal® 100 mg tablets
Intervention description: 1 x 100 mg; 1 x 100 mg
Intervention MeSH terms: Cilostazol
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      The objective of this randomized, single-dose, two-way evaluation is to compare the
      bioequivalence of a test cilostazol formulation to an equivalent oral dose of the
      commercially available cilostazol in a test population of 36 adult subjects under fasting
      conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sex: Male and Female; similar proportion of each preferred. Female subjects must be
             surgically sterile for at least six (6) months or postmenopausal for at least one (1)
             year.

          -  Age: At least 18 years.

          -  Weight: Body Mass Index (BMI) of 30 or less.

          -  Qualifying subjects must be in good health and physical condition as determined by
             medical history, complete physical examination, and laboratory test, all obtained
             within four (4) weeks prior to study start. The subject may not have a history of
             significant past illness expected to affect the investigation. The normal status of
             subjects will be confirmed by the following procedures:

          -  Laboratory Tests:

        Hemoglobin, hematocrit, RBC, WBC, differential count, serum electrolytes (Na, K, Cl),
        fasting blood glucose, BUN, bilirubin, creatinine, AST, ALT, LD, alkaline phosphatase, and
        urinalysis. HIV, Hepatitis B, Hepatitis C, and drugs of abuse testing will be done for
        screening purposes only. Urine drugs of abuse testing will be repeated at each check-in.
        Female subjects will have a serum pregnancy test done at screening and a urine pregnancy
        test prior to each study period at check-in.

        Laboratory values which are greater than 20% of the normal range will not qualify unless
        specifically accepted (with comment) by the Principal Investigator. Results of HIV,
        Hepatitis B, Hepatitis C, and drugs of abuse must be negative or non-reactive for the
        subject to qualify for the study.

          -  Electrocardiogram A 12-lead electrocardiogram (ECG) will be obtained for all subjects.
             The original tracings, plus interpretation, will be included in the case report form
             packet.

          -  Subjects must read and sign the Consent Form.

        Exclusion Criteria:

          -  History of treatment for alcoholism, substance abuse, or drug abuse within past 24
             months.

          -  History of sensitivity to cilostazol, quinolones, or any antiplatelet drug.

          -  History of malignancy, stroke, diabetes, cardiac, renal or liver disease or other
             serious illness.

          -  History of GERD (gastroesophageal reflux disease), malabsorption syndrome, colon
             cancer, or chronic colitis, including Crohn's disease.

          -  History of treatment for pulmonary obstruction or asthma within the past five (5)
             years.

          -  History of severe headaches or migraines.

          -  History of glaucoma.

          -  History of chronic infectious disease.

          -  History of psychiatric disorder.

          -  History of thyroid disorder/disease.

          -  History of hypertension.

          -  Females who are capable of becoming pregnant or are lactating.

          -  Inability to read and/or sign the consent form.

          -  Treatment with any other investigational drug during the four (4) weeks prior to the
             initial dosing for this study.

          -  Subjects who have donated blood within four (4) weeks prior to the initial dosing for
             this study.

          -  Subjects who smoke or use tobacco products or are currently using nicotine products
             (patches, gums, etc.). Three months abstinence is required.