InteractionNCT01482117
The Effect of Genetic Polymorphism on Interactions of Clopidogrel and Cilostazol in Healthy Volunteers
A study testing Clopidogrel, Cilostazol and Clopidogrel/Cilostazol in people with Interaction, run by Inje University.
Trial summary
The aim of this study is to investigate the effects of genetic polymorphisms on pharmacokinetic and pharmacodynamic interactions of clopidogrel and cilostazol in Korean healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Interaction
- What is being tested?
- Clopidogrel, Cilostazol and Clopidogrel/Cilostazol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Feb 2012
- Phase
- Interventional
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subject whose CYP2C19 genotype was determined
Who cannot join
- Subject who has abnormal laboratory test results
About this study
Official title: Randomized, Open-label, Crossover Study to Evaluate the Effect of Genetic Polymorphism on Pharmacokinetic & Pharmacodynamic Interactions of Clopidogrel and Cilostazol in Korean Healthy Adult Volunteers
The aim of this study is to investigate the effects of genetic polymorphisms on pharmacokinetic and pharmacodynamic interactions of clopidogrel and cilostazol in Korean healthy adult volunteers.
- Conditions
- Interaction
- Being tested
- Clopidogrel, Cilostazol, Clopidogrel/Cilostazol
- Keywords
- CYP2C19, CYP3A5, Clopidogrel, Cilostazol, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Also called Plavix
single oral administration of 300mg of clopidogrel
CilostazolDrug
Also called Pletaal
single oral administration of 100mg cilostazol
Clopidogrel/CilostazolDrug
Also called Plavix/Pletaal
single oral administration of 300mg clopidogrel and 100mg cilostazol
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Active comparator | single oral administration of 300mg of clopidogrel Receives: Drug: Clopidogrel; Drug: Cilostazol; Drug: Clopidogrel/Cilostazol |
| Cilostarole | Active comparator | single oral administration of 100mg of cilostazole Receives: Drug: Clopidogrel; Drug: Cilostazol; Drug: Clopidogrel/Cilostazol |
| Clopidogrel/Cilostazol | Active comparator | single oral administration of 300mg clopidogrel and 100mg cilostazol Receives: Drug: Clopidogrel; Drug: Cilostazol; Drug: Clopidogrel/Cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration(Cmax), Area under the concentration(AUC), Inhibition of platelet aggregation(IPA)
9 or 11 point blood sampling according to the interventions
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InteractionStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Gook Shin, Inje University
- Investigators
- Jae-Gook Shin, MD, PhD, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482117
- Sponsor's protocol ID
- 10-105
- Status last verified
- May 2013
- First submitted
- 26 Nov 2011
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label, Crossover Study to Evaluate the Effect of Genetic Polymorphism on Pharmacokinetic & Pharmacodynamic Interactions of Clopidogrel and Cilostazol in Korean Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01482117
- Acronym / sponsor ID
- 10-105
- Conditions
- Interaction
- Keywords
- CYP2C19, CYP3A5, Clopidogrel, Cilostazol, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 30 Nov 2011 (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 aim of this study is to investigate the effects of genetic polymorphisms on pharmacokinetic and pharmacodynamic interactions of clopidogrel and cilostazol in Korean healthy adult volunteers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | Active comparator | Drug: Clopidogrel, Drug: Cilostazol, Drug: Clopidogrel/Cilostazolsingle oral administration of 300mg of clopidogrel |
| Cilostarole | Active comparator | Drug: Clopidogrel, Drug: Cilostazol, Drug: Clopidogrel/Cilostazolsingle oral administration of 100mg of cilostazole |
| Clopidogrel/Cilostazol | Active comparator | Drug: Clopidogrel, Drug: Cilostazol, Drug: Clopidogrel/Cilostazolsingle oral administration of 300mg clopidogrel and 100mg cilostazol |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male subject whose CYP2C19 genotype was determined
Key exclusion criteria (1 listed)
- Subject who has abnormal laboratory test results
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 |
|---|---|---|
| ClopidogrelAlso: Plavixsingle oral administration of 300mg of clopidogrel | Drug | Cilostarole, Clopidogrel, Clopidogrel/Cilostazol |
| CilostazolAlso: Pletaalsingle oral administration of 100mg cilostazol | Drug | Cilostarole, Clopidogrel, Clopidogrel/Cilostazol |
| Clopidogrel/CilostazolAlso: Plavix/Pletaalsingle oral administration of 300mg clopidogrel and 100mg cilostazol | Drug | Cilostarole, Clopidogrel, Clopidogrel/Cilostazol |
Primary outcome
Maximum concentration(Cmax), Area under the concentration(AUC), Inhibition of platelet aggregation(IPA)
Time frame: up to 24 hours
9 or 11 point blood sampling according to the interventions
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 3 Jun 2013.
Related trials for Interaction
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
RecruitingObservational study
Molecular Basis of Human Phagocyte Interactions With Bacterial Pathogens
Host Defense Mechanisms
RecruitingPhase 1
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Healthy Volunteer, Pharmacokinetics
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.
Jae-Gook Shin, MD, PhD principal investigator
Inje University
Questions about this trial
What is this clinical trial studying?
A study testing Clopidogrel, Cilostazol and Clopidogrel/Cilostazol in people with Interaction, run by Inje University.
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 1 inclusion and 1 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 3 Jun 2013. 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.
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?
Maximum concentration(Cmax), Area under the concentration(AUC), Inhibition of platelet aggregation(IPA) (time frame: up to 24 hours). 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 3 Jun 2013.