DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Fasted Bioavailability Study of Cilostazol Tablets, 100 mg

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

Intervention: Cilostazol 100 mg Tablets (Drug); Cilostazol (Pletal®) 100 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, 100mg Under Fasting Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

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-∞)]

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 (1 x 100 mg tablet), or a single oral dose of the reference formulation, Pletal® (1 x 100 mg tablet). 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 (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

Locations and Contacts

Additional Information

Recalls, Market Withdrawals and Safety Alerts

Daily Med - Posting of Recently Submitted Labeling to the FDA

Starting date: March 2004
Last updated: November 18, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017