Fasted Bioavailability Study of Cilostazol Tablets, 100 mg

NCT00684762 | Completed Phase 1 Results

• 1 other identifier: 11788
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Therapeutic Equivalency

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax)

  The maximum or peak concentration that cilostazol (test and reference product) reaches in the plasma.

  serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.

• Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]

  The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable cilostazol (test and reference) concentration (t), as calculated by the linear trapezoidal rule.

  serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.

• Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]

  The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable cilostazol (reference and test) plasma concentration to the elimination rate constant.

  serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.

Study Arms (2)

Cilostazol

EXPERIMENTAL

A single dose of cilostazol (1 x 100 mg tablet) administered after an overnight fast of at least 10 hours.

Drug: Cilostazol 100 mg Tablets

Pletal® (cilostazol)

EXPERIMENTAL

A single dose of cilostazol (Pletal® 1 x 100 mg tablet) administered after an overnight fast of at least 10 hours.

Drug: Cilostazol (Pletal®) 100 mg Tablets

Interventions

Cilostazol 100 mg Tablets DRUG

Cilostazol (1 x 100 mg tablet) administered after an overnight fast of at least 10 hours

Cilostazol

Cilostazol (Pletal®) 100 mg Tablets DRUG

Cilostazol (Pletal® 1 x 100mg tablet) administered after an overnight fast of at least 10 hours.

Also known as: Pletal®

Pletal® (cilostazol)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mutual Pharmaceutical Company, Inc.: lead

Related Links

• Recalls, Market Withdrawals and Safety Alerts
• Daily Med - Posting of Recently Submitted Labeling to the FDA

MeSH Terms

Interventions

Cilostazol

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Medical Director
• Organization: Mutual Pharmaceutical Company, Inc.

clinicaltrials@urlmutual.com

215-697-1743

Study Officials

• Dilip K Guha-Ray, M.D.

  BASi Baltimore Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 24, 2008
• First Posted: May 28, 2008
• Study Start: March 1, 2004
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: December 22, 2009
• Results First Posted: December 22, 2009

Record last verified: 2009-11