Fasted Bioavailability Study of Cilostazol Tablets, 50mg
Information source: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Therapeutic Equivalency, Healthy
Intervention: Cilostazol 50 mg Tablets (Drug); Cilostazol (PletalĀ®) 50 mg Tablets (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mutual Pharmaceutical Company, Inc. Official(s) and/or principal investigator(s): Dilip K Guha-Ray, M.D., Principal Investigator, Affiliation: BASi Baltimore Clinical Research Unit
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.
Clinical Details
Official title: A Comparative Bioavailability Study of Cilostazol Tablets, 50mg, Under Fasting Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Maximum Plasma Concentration (Cmax)Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-ā)]
Detailed description:
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 receive either a single oral dose of
the test formulation, cilostazol (2 x 50 mg tablets), or a single oral dose of the reference
formulation, PletalĀ® (2 x 50 mg tablets). After a 7 day washout period on the morning of Day
8, following an overnight fast of at least 10 hours, subjects will receive the alternate
regimen. Blood samples will be drawn from all participants before dosing and for 24 hours
post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics
of cilostazol. Blood sampling will then continue on a non-confined basis at 36 and 48 hours
post-dose. A further goal of this study is to evaluate the safety and tolerability of this
regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion
of the study for adverse reactions to the study drug and/or procedures. Blood pressure and
pulse will be measured before dosing and at 3 and 24 hours post-dose. All adverse events
whether elicited by query, spontaneously reported, or observed by clinic staff will be
evaluated by the investigator and reported in the subject's case report form.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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 urine screening of drugs of abuse
- Positive results to Human Immunodeficiency Virus (HIV) or Hepatitis B surface Antigen
(HBsAg) tests
- Participation in another clinical trial in the previous 30 days before day 1 of this
study
- Donation of blood in the previous 30 days before day 1 of this study
Locations and Contacts
Additional Information
Recalls, Market Withdrawals and Safety Alerts Daily Med - Posting of Recently Submitted Labeling to the FDA
Starting date: June 2004
Last updated: November 18, 2009
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