Clinical trial NCT03671941: Clinical Study to Compare the Pharmacokinetic Characteristics and Safety Between CKD-357 and D578 in Healthy Volunteers
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Evaluate Pharmacokinetic Profiles and Safety/Tolerability of CKD-357 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Coronary Syndrome
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-09-14
Enrollment: 31
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: AUCt of Ticagrelor
timeFrame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
measure: Cmax of Ticagrelor
timeFrame: 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:
measure: AUCinf of Ticagrelor
timeFrame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
measure: Tmax of Ticagrelor
timeFrame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
measure: t1/2 of Ticagrelor
timeFrame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
measure: CL/F of Ticagrelor
timeFrame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
measure: Vd/F of Ticagrelor
timeFrame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
measure: AUCt of AR-C124910XX
timeFrame: 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
measure: Cmax of AR-C124910XX
timeFrame: 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
measure: AUCinf of AR-C124910XX
timeFrame: 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
measure: Tmax of AR-C124910XX
timeFrame: 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
measure: t1/2 of AR-C124910XX
timeFrame: 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
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
affiliation: Chonbuk National University Hospital
name: Kyung-Ho Jang, Professor
role: PRINCIPAL_INVESTIGATOR
References: