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

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ClinicalTrials.gov Identifier: NCT03671941
Recruitment Status : Completed
First Posted : September 14, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: D578 Drug: CKD-357 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Single Dose, Crossover Study to Evaluate Pharmacokinetic Profiles and Safety/Tolerability of CKD-357 in Healthy Volunteers
Actual Study Start Date : May 25, 2018
Actual Primary Completion Date : June 4, 2018
Actual Study Completion Date : June 18, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Arm Intervention/treatment
Active Comparator: Group A
D578 Tab. 1T
Drug: D578
D578 Tab.1T single oral administration under fasting condition
Other Name: Ticagrelor

Experimental: Group B
CKD-357 Tab. 1T
Drug: CKD-357
CKD-357 Tab.1T single oral administration under fasting condition
Other Name: Novel salts of Ticagrelor




Primary Outcome Measures :
  1. 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 ]
    Area under the plasma concentration of Ticagrelor versus time curve from time zero to time of last quantifiable concentration

  2. Cmax 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 ]
    Maximum plasma concentration of Ticagrelor


Secondary Outcome Measures :
  1. AUCinf 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 ]
    Area under the plasma concentration of Ticagrelor versus time curve from time zero to time infinity

  2. Tmax 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 ]
    Time to maximum concentration of of Ticagrelor

  3. t1/2 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 ]
    Apparent terminal half-life of Ticagrelor

  4. CL/F 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 ]
    Total body clearance of Ticagrelor

  5. Vd/F 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 ]
    Apparent volume of distribution of Ticagrelor

  6. AUCt of AR-C124910XX [ Time Frame: 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 ]
    Area under the plasma concentration of AR-C124910XX versus time curve from time zero to time of last quantifiable concentration

  7. Cmax of AR-C124910XX [ Time Frame: 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 ]
    Maximum plasma concentration of AR-C124910XX

  8. AUCinf of AR-C124910XX [ Time Frame: 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 ]
    Area under the plasma concentration of AR-C124910XX versus time curve from time zero to time infinity

  9. Tmax of AR-C124910XX [ Time Frame: 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 ]
    Time to maximum concentration of AR-C124910XX

  10. t1/2 of AR-C124910XX [ Time Frame: 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 ]
    Apparent terminal half-life of AR-C124910XX



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

[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

    a. ALT or AST > twice higher than normal value

  4. 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)
  5. Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial.
  6. Whose blood pressure < 100 or ≥140(systolic blood pressure) or < 70 or ≥ 90(diastolic blood pressure)
  7. Who had a medical history of alcohol and drug abuses.
  8. 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.
  9. Who smokes more than 20 cigarettes per day within 6 months of the screening
  10. Who took prescribed drugs or over-the-counter drugs in 10 days before taking of very first clinical testing drug.
  11. 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
  12. 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.
  13. Who has a history of an extreme sensitivity of composition of the drug
  14. Who has hemorrhagic tendency(recently trauma, recently surgery, coagulation disorder, recently gastrointestinal bleeding)and are scheduled for surgery within one month
  15. Who has a potent to increase a danger of beat heart slowly like symptom of bradycardia and dyspnea
  16. Who had a medical history of hyperuricacidemia and gouty arthritis
  17. Who has a Pregnant or potentially pregnant.
  18. A person who is not determined unsuitable to participate in this test by the researchers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671941


Locations
Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Kyung-Ho Jang, Professor Chonbuk National University Hospital

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03671941     History of Changes
Other Study ID Numbers: 180BE18003
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs