Coronary Artery DiseasePhase 1NCT01663038
Comparative Pharmacokinetics Study of Clopidogrel and Aspirin Fixed-dose Combination Versus Separate Combination
A Phase 1 study testing Clopidogrel, Fixed dose combination of clopidogrel/Aspirin and Aspirin in people with Coronary Artery Disease, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to compare pharmacokinetics between fixed-dose combination and separate combination of clopidogrel 75mg/aspirin 100mg. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Clopidogrel, Fixed dose combination of clopidogrel/Aspirin and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Sep 2011
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A healthy male volunteer aged 20 to 55, and within 20% of ideal body weight.
- Have not any congenital or chronic diseases and medical symptom.
- Appropriate subject for the study judging from examinations(interview, vital signs, 12-lead ECG, physical examination, blood, urinalysis result on screening.
- Able to participate in the entire trial.
- Signed the informed consent form prior to study participation.
Who cannot join
- Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first IP administration.
- show evidence of acute disease within 28 days prior to the first IP administration.
- Have the medical history of bleeding symptom or bleeding disease
- Have the disease history(ex. Inflammatory intestinal disease, stomach or duodenum ulcer, liver and bowels disease, appendectomy except of gastrointestinal surgery history) that may influence on the absorption, distribution, metabolism and excretion of the drug.
- Have relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that does not need medication.
- Have hypersensitivity reaction histories for Clopidogrel or aspirin.
Show all 13Show fewer
- Have abnormal laboratory result. AST or ALT > 1.25 times of upper limit/ Total bilirubin > 1.5 times of upper limit/ PT, aPTT, BT over upper limit/ Platelet count <150X10^9/L or >350X10^9/L
- A drug abuse or a heavy caffeine consumer (more than 5cups per a day) or a heavy smoker (more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first IP administration.
- Have a diet(Especially, grapefruit juice-within 7days prior to the first IP administration) that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
- Have donated whole blood within 60 days prior to the first IP administration.
- Participated in the other clinical trials within 90days prior to the first IP administration.
- Take medicine which affect to this trial within 10 days prior to the first IP administration.
- Appropriate subject for the trial judging from principal investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Pharmacokinetics of Clopidogrel 75mg and Aspirin 100mg After Single Oral Administration as a Fixed Dose Combination Versus Separate Combination in Healthy Male Volunteers
The purpose of this study is to compare pharmacokinetics between fixed-dose combination and separate combination of clopidogrel 75mg/aspirin 100mg.
- Conditions
- Coronary Artery Disease
- Being tested
- Clopidogrel, Fixed dose combination of clopidogrel/Aspirin, Aspirin
- Keywords
- Clopidogrel, Aspirin, Combination, Pharmacokinetics, Phase 1
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Also called Clopidogrel: Plavix
Clopidogrel and Aspirin separate combination, single dose
Fixed dose combination of clopidogrel/AspirinDrug
Also called Coprigrel
Fixed dose combination of clopidogrel/aspirin
AspirinDrug
Also called Aspirin: Astrix
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel and Aspirin | Active comparator | Not described Receives: Drug: Clopidogrel; Drug: Aspirin |
| Copidogrel | Experimental | Not described Receives: Drug: Fixed dose combination of clopidogrel/Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of clopidogrel/acetylsalicylic acid
Measured: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
AUC of clopidogrel/acetylsalicylic acid
Measured: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
Secondary outcomes (2)
Assess Cmax of salicylic acid.
Measured: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
Assess AUC of salicylic acid.
Measured: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startDec 2010
- Primary completionJan 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inje University
- Responsible party
- Sponsor
- Investigators
- JH Shon, Ph.D, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663038
- Sponsor's protocol ID
- 119HPS10F
- Status last verified
- Aug 2012
- First submitted
- 20 Dec 2010
- Last updated
- 13 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacokinetics of Clopidogrel 75mg and Aspirin 100mg After Single Oral Administration as a Fixed Dose Combination Versus Separate Combination in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01663038
- Acronym / sponsor ID
- 119HPS10F
- Conditions
- Coronary Artery Disease
- Keywords
- Clopidogrel, Aspirin, Combination, Pharmacokinetics, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Inje University
- Study start
- Dec 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 13 Aug 2012 (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 purpose of this study is to compare pharmacokinetics between fixed-dose combination and separate combination of clopidogrel 75mg/aspirin 100mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel and Aspirin | Active comparator | Drug: Clopidogrel, Drug: Aspirin |
| Copidogrel | Experimental | Drug: Fixed dose combination of clopidogrel/Aspirin |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A healthy male volunteer aged 20 to 55, and within 20% of ideal body weight.
- Have not any congenital or chronic diseases and medical symptom.
- Appropriate subject for the study judging from examinations(interview, vital signs, 12-lead ECG, physical examination, blood, urinalysis result on screening.
- Able to participate in the entire trial.
- Signed the informed consent form prior to study participation.
Key exclusion criteria (13 listed)
- Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first IP administration.
- show evidence of acute disease within 28 days prior to the first IP administration.
- Have the medical history of bleeding symptom or bleeding disease
- Have the disease history(ex. Inflammatory intestinal disease, stomach or duodenum ulcer, liver and bowels disease, appendectomy except of gastrointestinal surgery history) that may influence on the absorption, distribution, metabolism and excretion of the drug.
- Have relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that does not need medication.
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: Clopidogrel: PlavixClopidogrel and Aspirin separate combination, single dose | Drug | Clopidogrel and Aspirin |
| Fixed dose combination of clopidogrel/AspirinAlso: CoprigrelFixed dose combination of clopidogrel/aspirin | Drug | Copidogrel |
| AspirinAlso: Aspirin: Astrix | Drug | Clopidogrel and Aspirin |
Primary outcome
Cmax of clopidogrel/acetylsalicylic acid
Time frame: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
AUC of clopidogrel/acetylsalicylic acid
Time frame: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
2 secondary outcomes
Assess Cmax of salicylic acid.
Time frame: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
Assess AUC of salicylic acid.
Time frame: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
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 13 Aug 2012.
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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.
JH Shon, Ph.D principal investigator
Inje University
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 Clopidogrel, Fixed dose combination of clopidogrel/Aspirin and Aspirin in people with Coronary Artery Disease, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
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 5 inclusion and 13 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 13 Aug 2012. 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 South Korea. 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?
Cmax of clopidogrel/acetylsalicylic acid (time frame: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h). The study lists 2 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 13 Aug 2012.