Acute Coronary SyndromePhase 1NCT01657071
Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects
A Phase 1 study testing YH14659 and clopidogrel & aspirin in people with Acute Coronary Syndrome, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
The objective of this study is to compare pharmacokinetics after single oral administration of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in healthy male volunteers. 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
- Acute Coronary Syndrome
- What is being tested?
- YH14659 and clopidogrel & aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Apr 2012
- 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
- Healthy male volunteers of aged between 20 years to 55 years
- Weight: over 50kg, within ±20% of ideal body weight
- Have no history of neither congenital nor chronic disease
- Have no history of abnormal symptoms or opinions as a result of physical examination (medical checkup)
- Eligible subjects with acceptable medical history, physical examination, laboratory tests, ECG during screening period
- Subject who has signed on the written consent
Who cannot join
- Have a known allergy or hypersensitivity to anti-platelet agents
- Person with hypotension (SBP ≤ 100mmHg or DBP ≤ 50mmHg) or hypertension (SBP ≥ 150mmHg or DBP ≥ 95mmHg), person whose pulse rate is below 45 or over 100 a minute
- Have the following abnormal findings on diagnosis;
- have AST or ALT > 1.25 times of normal upper limit
- have total bilirubin > 1.5 times of normal upper limit
- have higher PT, aPPT, BT than normal range
Show all 13Show fewer
- have PLT below 180,000 or above 350,000
- Patients with hemorrhage or predisposition to hemorrhage
- Have disease or history of stomach or intestinal surgery or resection that would potentially alter absorption of orally administered drugs
- Have participated in other clinical studies within 3 months prior to the first administration
- Have used any prescription medications including anti-coagulants, anti-platelet agents, thrombolytic drugs and Prostaglandin E1 agents within 2 weeks prior to the first administration or any over-the-counter, non-prescription preparations within 1 week prior to the first administration
- Patients with aspirin induced asthma(AIA) or history of AIA
- Subject who is judged to be ineligible by principal investigator or sub-investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, 2-treatment, 2-period, 2-way Crossover Study to Assess the Pharmacokinetic Characteristics of YH14659, a Fixed Dose Combination Compared With Coadministration of Separate Constituents Under Fasted Conditions in Healthy Male Subjects
The objective of this study is to compare pharmacokinetics after single oral administration of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in healthy male volunteers.
- Conditions
- Acute Coronary Syndrome
- Being tested
- YH14659, clopidogrel & aspirin
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH14659Drug
YH14659 capsule by oral
clopidogrel & aspirinDrug
clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: YH14659 |
| Group B | Active comparator | Not described Receives: Drug: clopidogrel & aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax and AUCt of clopidogrel
Measured: 24hrs
Cmax and AUCt of Acetylsalicylic acid
Measured: 24hrs
Secondary outcomes (2)
Tmax, T1/2, λz and AUC∞ of Clopidogrel and Acetylsalicylic acid - AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid
Measured: 24hrs
AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid
Measured: 24hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe 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
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jang-Hee Hong, M.D., Ph.D., Principal investigator, Chung-Nam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657071
- Sponsor's protocol ID
- YH14659-102
- Status last verified
- Jul 2012
- First submitted
- 21 Mar 2012
- Last updated
- 3 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, 2-treatment, 2-period, 2-way Crossover Study to Assess the Pharmacokinetic Characteristics of YH14659, a Fixed Dose Combination Compared With Coadministration of Separate Constituents Under Fasted Conditions in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01657071
- Acronym / sponsor ID
- YH14659-102
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 3 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 objective of this study is to compare pharmacokinetics after single oral administration of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: YH14659 |
| Group B | Active comparator | Drug: clopidogrel & aspirin |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male volunteers of aged between 20 years to 55 years
- Weight: over 50kg, within ±20% of ideal body weight
- Have no history of neither congenital nor chronic disease
- Have no history of abnormal symptoms or opinions as a result of physical examination (medical checkup)
- Eligible subjects with acceptable medical history, physical examination, laboratory tests, ECG during screening period
Key exclusion criteria (13 listed)
- Have a known allergy or hypersensitivity to anti-platelet agents
- Person with hypotension (SBP ≤ 100mmHg or DBP ≤ 50mmHg) or hypertension (SBP ≥ 150mmHg or DBP ≥ 95mmHg), person whose pulse rate is below 45 or over 100 a minute
- Have the following abnormal findings on diagnosis;
- Patients with hemorrhage or predisposition to hemorrhage
- Have disease or history of stomach or intestinal surgery or resection that would potentially alter absorption of orally administered drugs
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 |
|---|---|---|
| YH14659YH14659 capsule by oral | Drug | Group A |
| clopidogrel & aspirinclopidogrel tablet(75mg) + aspirin capsules(100mg) by oral | Drug | Group B |
Primary outcome
Cmax and AUCt of clopidogrel
Time frame: 24hrs
Cmax and AUCt of Acetylsalicylic acid
Time frame: 24hrs
2 secondary outcomes
Tmax, T1/2, λz and AUC∞ of Clopidogrel and Acetylsalicylic acid - AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid
Time frame: 24hrs
AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid
Time frame: 24hrs
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 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.
Jang-Hee Hong, M.D., Ph.D. principal investigator
Chung-Nam National University Hospital
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 YH14659 and clopidogrel & aspirin in people with Acute Coronary Syndrome, run by Yuhan Corporation 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 6 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 3 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 and AUCt of clopidogrel (time frame: 24hrs). 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 3 Aug 2012; AzTrials last refreshed its copy on 8 Nov 2026.