Therapeutic EquivalencyPhase 1NCT00684762
Fasted Bioavailability Study of Cilostazol Tablets, 100 mg
A Phase 1 study testing Cilostazol 100 mg Tablets and Cilostazol (Pletal®) 100 mg Tablets in people with Therapeutic Equivalency, run by Mutual Pharmaceutical Company, Inc..
Trial 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 more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Equivalency
- What is being tested?
- Cilostazol 100 mg Tablets and Cilostazol (Pletal®) 100 mg Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Mar 2004
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: A Comparative Bioavailability Study of Cilostazol Tablets, 100mg Under Fasting Conditions
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.
- Conditions
- Therapeutic Equivalency
- Being tested
- Cilostazol 100 mg Tablets, Cilostazol (Pletal®) 100 mg Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilostazol 100 mg TabletsDrug
Cilostazol (1 x 100 mg tablet) administered after an overnight fast of at least 10 hours
Cilostazol (Pletal®) 100 mg TabletsDrug
Also called Pletal®
Cilostazol (Pletal® 1 x 100mg tablet) administered after an overnight fast of at least 10 hours.
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol | Experimental | A single dose of cilostazol (1 x 100 mg tablet) administered after an overnight fast of at least 10 hours. Receives: 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. Receives: Drug: Cilostazol (Pletal®) 100 mg Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
The maximum or peak concentration that cilostazol (test and reference product) reaches in the plasma.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startMar 2004
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Therapeutic EquivalencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mutual Pharmaceutical Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dilip K Guha-Ray, M.D., Principal investigator, BASi Baltimore Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684762
- Sponsor's protocol ID
- 11788
- Status last verified
- Nov 2009
- First submitted
- 24 May 2008
- Last updated
- 22 Dec 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Bioavailability Study of Cilostazol Tablets, 100mg Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00684762
- Acronym / sponsor ID
- 11788
- Conditions
- Therapeutic Equivalency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mutual Pharmaceutical Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 28 May 2008 (estimated)
- Results
- Posted 22 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cilostazol | Experimental | Drug: Cilostazol 100 mg TabletsA single dose of cilostazol (1 x 100 mg tablet) administered after an overnight fast of at least 10 hours. |
| Pletal® (cilostazol) | Experimental | Drug: Cilostazol (Pletal®) 100 mg TabletsA single dose of cilostazol (Pletal® 1 x 100 mg tablet) administered after an overnight fast of at least 10 hours. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cilostazol 100 mg TabletsCilostazol (1 x 100 mg tablet) administered after an overnight fast of at least 10 hours | Drug | Cilostazol |
| Cilostazol (Pletal®) 100 mg TabletsAlso: Pletal®Cilostazol (Pletal® 1 x 100mg tablet) administered after an overnight fast of at least 10 hours. | Drug | Pletal® (cilostazol) |
Primary outcome
Maximum Plasma Concentration (Cmax)
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.
The maximum or peak concentration that cilostazol (test and reference product) reaches in the plasma.
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
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.
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.
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Recalls, Market Withdrawals and Safety AlertsLink provided by the sponsor.
- Daily Med - Posting of Recently Submitted Labeling to the FDALink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilip K Guha-Ray, M.D. principal investigator
BASi Baltimore Clinical Research Unit
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cilostazol 100 mg Tablets and Cilostazol (Pletal®) 100 mg Tablets in people with Therapeutic Equivalency, run by Mutual Pharmaceutical Company, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2009.