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
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.
