Cilostazol 50 mg Tablets Under Fasting Conditions
Condition: Healthy
Intervention: Cilostazol 50 mg Tablets; Pletal®
Intervention description: 1 x 50 mg, single-dose fasting; 1 x 50 mg, single-dose tablet
Intervention MeSH terms: Cilostazol
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      This study will compare the relative bioavailability (rate and extent of absorption) of 50 mg
      Cilostazol Tablets manufactured by TEVA Pharmaceuticals Industries Ltd. and distributed by
      TEVA Pharmaceuticals USA with that of PLETAL Tablets manufactured by Otsuka Pharmaceuticals
      Co., Ltd. for Otsuka America Pharmaceutical, Inc. following a single oral dose (1 x 50 mg
      tablet) in healthy adult subjects administered under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Screening Demographics: All volunteers selected for this study will be healthy men or
             women 18 years of age or older at the time of dosing. The volunteer's body mass index
             (BMI) is less than or equal to 30.

          -  Screening Procedures: Each volunteer will complete the screening process within 28
             days prior to Period I dosing. Consent documents for both the screening evaluation and
             HIV antibody determination will be reviewed, discussed, and signed by each potential
             participant before full implementation of screening procedures.

        Screening will include general observations, physical examination, demographics, medical
        and medication history, an electrocardiogram, sitting blood pressure and heart rate,
        respiratory rate and temperature. The physical examination will include, but may not be
        limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory, and central
        nervous systems.

          -  The screening clinical laboratory procedures will include:

               -  Hematology: hematocrit, hemoglobin, RBC count, WBC count with differential,
                  platelet count;

               -  Clinical Chemistry: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin,
                  total bilirubin, total protein, and alkaline phosphatase.

               -  HIV antibody and hepatitis B surface antigen and hepatitis C antibody screens;

               -  Urinalysis: by dipstick; full microscopic examination if dipstick positive; and

               -  Urine Drug Screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines,
                  cannabinoids, cocaine metabolites, opiates, and phencyclidine;

               -  Serum Pregnancy Screen (female volunteers only).

               -  Follicle Stimulating Hormone (FSH; female subjects only): verify postmenopausal
                  status

          -  If female and:

               -  is postmenopausal for at least 1 year with postmenopausal status defined as: > 60
                  years of age and amenorrheic for at least one year; if 60 years of age or
                  younger, must also have a serum FSH level >30 IU/L; or

               -  is surgically sterile for at least 6 months (bilateral tubal ligation, bilateral
                  oophorectomy, or hysterectomy).

        Exclusion Criteria:

          -  Volunteers with a recent history of drug or alcohol addiction or abuse.

          -  Volunteers with the presence of a clinically significant disorder involving the
             cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic,
             endocrine, or neurologic system(s) or psychiatric disease (as determined by the
             clinical investigators).

          -  Volunteers whose clinical laboratory test values are outside the accepted reference
             range and when confirmed on re-examination are deemed to be clinically significant.

          -  Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive
             HIV antibody screen.

          -  Volunteers demonstrating a positive drug abuse screen when screened for this study.

          -  Female volunteers demonstrating a positive pregnancy screen.

          -  Female volunteers who are currently breastfeeding.

          -  Volunteers with a history of allergic response(s) to cilostazol or related drugs.

          -  Volunteers with a history of clinically significant allergies including drug
             allergies.

          -  Volunteers with a clinically significant illness during 4 weeks prior to Period I
             dosing (as determined by the clinical investigators).

          -  Volunteers who are currently using or report using tobacco products within 90 days
             prior to Period I dosing.

          -  Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism
             in the 30 days prior to Period I dosing.

          -  Volunteers who report donating greater than 150 mL of blood within 30 days prior to
             Period I dosing. All subjects will be advised not to donate blood for four weeks after
             completing the study.

          -  Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to
             Period I dosing. All subjects will be advised not to donate plasma for four weeks
             after completing the study.

          -  Volunteers who report receiving any investigational drug within 30 days prior to
             Period I dosing.

          -  Volunteers who report taking any prescription medication or nonprescription medication
             in the 14 days or 7 days, respectively, prior to Period I dosing with the exception of
             topical products without systemic absorption.

          -  Volunteers who have been on an abnormal diet during the 28 days prior to Period I
             dosing.

          -  Volunteers who report an intolerance or direct venipuncture.