Intermittent ClaudicationPhase 1NCT00773630
A Mono-center Study in Healthy Volunteers on the Comparative Bioavailability of Pletal 100 mg Tablets and a New Pletal 100 mg Orodispersible Tablet (ODT), This Latter in Fasting Conditions With and Without Water and Under Fed Conditions
A Phase 1 study testing Cilostazol in people with Intermittent Claudication, run by Otsuka Frankfurt Research Institute GmbH at 1 site in Germany.
Trial summary
The primary objective of this trial is to test whether Pletal ODT administered without water can be considered bioequivalent to Pletal administered with 200 ml water (both treatments being administered after fasting and at least 30 minutes prior to receiving a light breakfast) based on the standard pharmacokinetic… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Intermittent Claudication
- What is being tested?
- Cilostazol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2008to Mar 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male and female subjects of Caucasian race
- able to read, to write and to fully understand German language
- having given voluntary written informed consent before first invasive screening examination procedure
- aged 18 to 45 years, inclusive
- BMI of 18 - 28 kg/m2
- good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG, serum/urine biochemistry and hematology)
Who cannot join
- clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) drug hypersensitivity
- known hypersensitivity to one of the IMP substances
- severe digestive disorder or surgery of the digestive tract (except for appen¬dectomy)
- clinically relevant renal disorders (albuminuria, chronic infections)
- clinically relevant hepatic disorders
- clinically relevant respiratory disorders
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- clinically relevant cardiovascular disorders, especially any history of ventricular tachycardia, ventricular fibrillation or multifocal ventricular ectopics, or a history of additional risk factors for torsades de pointes (TdP) (e.g. heart failure, hypokalemia, congenital long QT-syndrome)
- diabetes mellitus and thyroid dysfunction or other endocrine disorders
- malignancy
- substance abuse or addiction (alcohol, illicit drugs) in the past 3 years
- neurologic or psychiatric illness
- known predisposition to bleeding (e.g. active peptic ulceration, recent (within 6 month) haemorrhagic stroke, surgery within the previous three months, proliferative diabetic retinopathy, poorly controlled hypertension)
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this trial is to test whether Pletal ODT administered without water can be considered bioequivalent to Pletal administered with 200 ml water (both treatments being administered after fasting and at least 30 minutes prior to receiving a light breakfast) based on the standard pharmacokinetic variables.
The secondary objective is to assess the effect of water and the effect of food on the administration of Pletal ODT based on standard pharmacokinetic variables.
- Conditions
- Intermittent Claudication
- Being tested
- Cilostazol
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilostazolDrug
100 mg Cilostazol
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Intake of Pletal 100 mg tablets dose together with 200 ml water Receives: Drug: Cilostazol |
| B | Experimental | Intake of Pletal 100 mg ODT dose without water Receives: Drug: Cilostazol |
| C | Experimental | Intake of Pletal 100 mg ODT dose together with 200 ml water Receives: Drug: Cilostazol |
| D | Active comparator | Intake of Pletal 100 mg ODT dose without water Receives: Drug: Cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve, maximal concentration (Cmax)
Measured: 1-2 months
Secondary outcomes (1)
Time of maximum (tmax), Vss/f, CL/f)
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ClaudicationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Frankfurt Research Institute GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margarete Mueller, Dr., Principal investigator, AAIPharma Deutschland GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773630
- Sponsor's protocol ID
- 21-08-101
- Status last verified
- Mar 2009
- First submitted
- 15 Oct 2008
- Last updated
- 9 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mono-center Study in Healthy Volunteers on the Comparative Bioavailability of Pletal 100 mg Tablets and a New Pletal 100 mg Orodispersible Tablet (ODT), This Latter in Fasting Conditions With and Without Water and Under Fed Conditions
- ClinicalTrials.gov ID
- NCT00773630
- Acronym / sponsor ID
- 21-08-101
- Conditions
- Intermittent Claudication
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Otsuka Frankfurt Research Institute GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 16 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to test whether Pletal ODT administered without water can be considered bioequivalent to Pletal administered with 200 ml water (both treatments being administered after fasting and at least 30 minutes prior to receiving a light breakfast) based on the standard pharmacokinetic variables.
The secondary objective is to assess the effect of water and the effect of food on the administration of Pletal ODT based on standard pharmacokinetic variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: CilostazolIntake of Pletal 100 mg tablets dose together with 200 ml water |
| B | Experimental | Drug: CilostazolIntake of Pletal 100 mg ODT dose without water |
| C | Experimental | Drug: CilostazolIntake of Pletal 100 mg ODT dose together with 200 ml water |
| D | Active comparator | Drug: CilostazolIntake of Pletal 100 mg ODT dose without water |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- healthy male and female subjects of Caucasian race
- able to read, to write and to fully understand German language
- having given voluntary written informed consent before first invasive screening examination procedure
- aged 18 to 45 years, inclusive
- BMI of 18 - 28 kg/m2
Key exclusion criteria (12 listed)
- clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) drug hypersensitivity
- known hypersensitivity to one of the IMP substances
- severe digestive disorder or surgery of the digestive tract (except for appen¬dectomy)
- clinically relevant renal disorders (albuminuria, chronic infections)
- clinically relevant hepatic disorders
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 |
|---|---|---|
| Cilostazol100 mg Cilostazol | Drug | A, B, C, D |
Primary outcome
Area under the curve, maximal concentration (Cmax)
Time frame: 1-2 months
1 secondary outcome
Time of maximum (tmax), Vss/f, CL/f)
Time frame: 1-2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2011.
Related trials for Intermittent Claudication
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Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
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Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
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.
Margarete Mueller, Dr. principal investigator
AAIPharma Deutschland GmbH & Co. KG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cilostazol in people with Intermittent Claudication, run by Otsuka Frankfurt Research Institute GmbH at 1 site in Germany.
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 6 inclusion and 12 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 9 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the curve, maximal concentration (Cmax) (time frame: 1-2 months). 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 9 Sep 2011.