Fasted Bioavailability Study of Cilostazol Tablets, 100 mg

Launched by MUTUAL PHARMACEUTICAL COMPANY, INC. · May 24, 2008

Keywords

ClinConnect 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. Thirty-two non-smoking, non-obese, healthy male and female volunteers between the ages of 18 and 55 will be randomly assigned in a crossover fashion to receive each of two cilostazol dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will recei...

Gender

ALL

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 results to Human Immunodeficiency Virus (HIV) or Hepatitis B surface Antigen (HBsAg) tests