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CompletedNCT00684762Updated Dec 22, 2009Results posted

Fasted Bioavailability Study of Cilostazol Tablets, 100 mg

A Phase 1 interventional study of Cilostazol 100 mg Tablets and Cilostazol (Pletal®) 100 mg Tablets in Therapeutic Equivalency, sponsored by Mutual Pharmaceutical Company, Inc.. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-12-22.

Sponsored by Mutual Pharmaceutical Company, Inc. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Therapeutic Equivalency
03

In context

Lead sponsor

Mutual Pharmaceutical Company, Inc. is the lead sponsor of 42 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Cilostazol

    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

  • Experimental
    Pletal® (cilostazol)

    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

  • DrugCilostazol 100 mg Tablets

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

  • DrugCilostazol (Pletal®) 100 mg Tablets

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

    Also known as: Pletal®

06

What researchers measure

Primary outcomes

  1. Maximum Plasma Concentration (Cmax)

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

    Time frame: 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.

  2. 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.

    Time frame: 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.

  3. 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.

    Time frame: 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.

07

Results

Posted Dec 22, 2009

Participant flow

First Intervention
Participant flow — First Intervention
MilestoneCilostazol 100 mg Tablets Then Pletal® 100 mg TabletsPletal® 100 mg Tablets Then Cilostazol 100 mg Tablets
Started1616
Completed1616
Not completed00
Washout Period of 7 Days
Participant flow — Washout Period of 7 Days
MilestoneCilostazol 100 mg Tablets Then Pletal® 100 mg TabletsPletal® 100 mg Tablets Then Cilostazol 100 mg Tablets
Started1616
Completed1414
Not completed22
Withdrew: Withdrawal by subject22
Second Intervention
Participant flow — Second Intervention
MilestoneCilostazol 100 mg Tablets Then Pletal® 100 mg TabletsPletal® 100 mg Tablets Then Cilostazol 100 mg Tablets
Started1414
Completed1414
Not completed00

Outcome measures

PrimaryMaximum Plasma Concentration (Cmax)

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

Time frame:
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.
Reported as:
Mean · ng/mL
Maximum Plasma Concentration (Cmax)
ng/mLCilostazol 100 mg TabletsPletal® 100 mg Tablets
Maximum Plasma Concentration (Cmax)484.895 ± 205.181472.689 ± 140.843
PrimaryArea 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.

Time frame:
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.
Reported as:
Mean · ng-hr/mL
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
ng-hr/mLCilostazol 100 mg TabletsPletal® 100 mg Tablets
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]6,518.90 ± 1,600.146,711.57 ± 1,895.25
PrimaryArea 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.

Time frame:
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.
Reported as:
Mean · ng-hr/mL
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
ng-hr/mLCilostazol 100 mg TabletsPletal® 100 mg Tablets
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]7,224.99 ± 1,786.617,650.45 ± 2,294.39

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cilostazol 100 mg Tablets—0/30 (0%)11/30 (36.7%)
Pletal® 100 mg Tablets—0/30 (0%)12/30 (40%)
Most frequent other events
Most frequent other events
EventCilostazol 100 mg TabletsPletal® 100 mg Tablets
HeadacheNervous system disorders6/306/30
Urine abnormalRenal and urinary disorders0/303/30
PainInjury, poisoning and procedural complications0/301/30
EosinophiliaInvestigations0/301/30
LymphadenoBlood and lymphatic system disorders1/300/30
HyperglycemiaMetabolism and nutrition disorders1/300/30
LDH increasedMetabolism and nutrition disorders1/300/30
SGOT increasedMetabolism and nutrition disorders1/300/30
ParesthesiaInjury, poisoning and procedural complications1/300/30
RhinitisRespiratory, thoracic and mediastinal disorders0/301/30

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Cilostazol 100 mg Tablets and Pletal® 100 mg Tablets
<=18 years0
Between 18 and 65 years32
>=65 years0
Age Continuous
Age Continuous(years)Cilostazol 100 mg Tablets and Pletal® 100 mg Tablets
Mean36.09 ± 11.63
Sex: Female, Male
Sex: Female, Male(Participants)Cilostazol 100 mg Tablets and Pletal® 100 mg Tablets
Female4
Male28
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cilostazol 100 mg Tablets and Pletal® 100 mg Tablets
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American21
White8
More than one race0
Unknown or Not Reported1
08

Study locations

No study locations are listed for this record.

09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00684762
Lead sponsor
Mutual Pharmaceutical Company, Inc.
First posted
May 28, 2008
Start date
Mar 2004
Primary completion
Mar 2004
Completion
Mar 2004
Results posted
Dec 22, 2009
Last update
Dec 22, 2009

Study contacts

Dilip K Guha-Ray, M.D.
principal investigator · BASi Baltimore Clinical Research Unit

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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