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Acute Coronary SyndromePhase 1NCT03671941

Clinical Study to Compare the Pharmacokinetic Characteristics and Safety Between CKD-357 and D578 in Healthy Volunteers

A Phase 1 study testing D578 and CKD-357 in people with Acute Coronary Syndrome, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A randomized, open-label, single dose, crossover study to evaluate pharmacokinetic profiles and safety/tolerability of CKD-357 in healthy volunteers Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
D578 and CKD-357
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteSouth Korea
Study dates
25 May 2018to 18 Jun 2018
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 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

[Inclusion Criteria]

  1. A healthy adult whose age is over 19 years old when visiting for initial screening test
  2. Body mass index(BMI) between 17.5~30.5 kg/m^2 and the body weight must be over 55kg (Body mass index (BMI) = weight (kg) / height (m)^2)
  3. A person with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area
  4. Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, viral/bacterial test, the electrocardiogram (ECG), and etc.
  5. The participants must be volunteered and sign in an informed consent document proven by Chonbuk National University IRB before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs.
  6. The participants must have an ability and willingness to participate throughout the entire trials

[Exclusion Criteria]

  1. A person who had a history or symptoms of clinically aware of blood, kidney, internal secretion, respiratory, gastrointestinal, urinary system, cardiovascular, liver, mental, nervous, or allergic(except subclinical seasonal allergies that is not treated at injection) disease.
  2. Who had a history of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy)
  3. Who had following results after examination
  4. ALT or AST > twice higher than normal value
  5. Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250 mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (!2%) (125 mL) = 12g)
  6. Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial.
  7. Whose blood pressure < 100 or ≥140(systolic blood pressure) or < 70 or ≥ 90(diastolic blood pressure)
  8. Who had a medical history of alcohol and drug abuses.
  9. Who had taken a drug that has a control of metabolic rate (activation or inhibition) in 30 days before the first taking of clinical testing durg.
  10. Who smokes more than 20 cigarettes per day within 6 months of the screening
  11. Who took prescribed drugs or over-the-counter drugs in 10 days before taking of very first clinical testing drug.
  12. Who participated in whole blood donation in 2 months before the first taking of clinical testing drugs or platelet donations in 1 month before the first taking to clinical testing drugs
  13. Who has a potent to increase a danger by participating in the clinical trials or sho can interrupt interpreting test results by having serious or chronic medical and mental status or having issues in results of the screening examination.
  14. Who has a history of an extreme sensitivity of composition of the drug
  15. Who has hemorrhagic tendency(recently trauma, recently surgery, coagulation disorder, recently gastrointestinal bleeding)and are scheduled for surgery within one month
  16. Who has a potent to increase a danger of beat heart slowly like symptom of bradycardia and dyspnea
  17. Who had a medical history of hyperuricacidemia and gouty arthritis
  18. Who has a Pregnant or potentially pregnant.
  19. A person who is not determined unsuitable to participate in this test by the researchers

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Chonbuk National University Hospital

    Jeonju

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Single Dose, Crossover Study to Evaluate Pharmacokinetic Profiles and Safety/Tolerability of CKD-357 in Healthy Volunteers

A randomized, open-label, single dose, crossover study to evaluate pharmacokinetic profiles and safety/tolerability of CKD-357 in healthy volunteers

Read the detailed description

To healthy subjects of thirty(30), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.

Being tested
D578, CKD-357
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.

  • D578Drug

    Also called Ticagrelor

    D578 Tab.1T single oral administration under fasting condition

  • CKD-357Drug

    Also called Novel salts of Ticagrelor

    CKD-357 Tab.1T single oral administration under fasting condition

Study groups in NCT03671941
Study groupRoleWhat they receive
Group AActive comparatorD578 Tab. 1T
Receives: Drug: D578
Group BExperimentalCKD-357 Tab. 1T
Receives: Drug: CKD-357

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUCt of Ticagrelor

    Area under the plasma concentration of Ticagrelor versus time curve from time zero to time of last quantifiable concentration

    Measured: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours

  2. Cmax of Ticagrelor

    Maximum plasma concentration of Ticagrelor

    Measured: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours

Secondary outcomes (10)
  1. AUCinf of Ticagrelor

    Area under the plasma concentration of Ticagrelor versus time curve from time zero to time infinity

    Measured: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours

  2. Tmax of Ticagrelor

    Time to maximum concentration of of Ticagrelor

    Measured: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours

  3. t1/2 of Ticagrelor

    Apparent terminal half-life of Ticagrelor

    Measured: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours

  4. CL/F of Ticagrelor

    Total body clearance of Ticagrelor

    Measured: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours

  5. Vd/F of Ticagrelor

    Apparent volume of distribution of Ticagrelor

    Measured: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours

  6. AUCt of AR-C124910XX

    Area under the plasma concentration of AR-C124910XX versus time curve from time zero to time of last quantifiable concentration

    Measured: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

  7. Cmax of AR-C124910XX

    Maximum plasma concentration of AR-C124910XX

    Measured: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

  8. AUCinf of AR-C124910XX

    Area under the plasma concentration of AR-C124910XX versus time curve from time zero to time infinity

    Measured: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

  9. Tmax of AR-C124910XX

    Time to maximum concentration of AR-C124910XX

    Measured: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

  10. t1/2 of AR-C124910XX

    Apparent terminal half-life of AR-C124910XX

    Measured: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start25 May 2018
  3. Primary completion4 Jun 2018
  4. Study completion18 Jun 2018

Resources

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
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03671941
Sponsor's protocol ID
180BE18003
Status last verified
Sep 2018
First submitted
13 Sep 2018
Last updated
19 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing D578 and CKD-357 in people with Acute Coronary Syndrome, 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?

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 19 Sep 2018. 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?

AUCt of Ticagrelor (time frame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours). 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 19 Sep 2018.

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