Overview

Fasted Bioavailability Study of Cilostazol Tablets, 100 mg

Status:
Completed
Trial end date:
2004-03-01
Target enrollment:
0
Participant gender:
All
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 PletalĀ® (cilostazol) tablets after a single oral dose administered under fasting conditions.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Treatments:
Cilostazol
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 (PletalĀ®), 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