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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03671941
• Other study ID #: 180BE18003
• Status: Completed
• Phase: Phase 1
• Start date: May 25, 2018
• Est. completion date: June 18, 2018

Study information

• Verified date: September 2018
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 18, 2018
• Est. primary completion date: June 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

[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

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Drug:
• D578
D578 Tab.1T single oral administration under fasting condition
• CKD-357
CKD-357 Tab.1T single oral administration under fasting condition

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Jeonju

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt of Ticagrelor	Area under the plasma concentration of Ticagrelor versus time curve from time zero to time of last quantifiable concentration	Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
Primary	Cmax of Ticagrelor	Maximum plasma concentration of Ticagrelor	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	AUCinf of Ticagrelor	Area under the plasma concentration of Ticagrelor versus time curve from time zero to time infinity	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	Tmax of Ticagrelor	Time to maximum concentration of of Ticagrelor	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	t1/2 of Ticagrelor	Apparent terminal half-life of Ticagrelor	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	CL/F of Ticagrelor	Total body clearance of Ticagrelor	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	Vd/F of Ticagrelor	Apparent volume of distribution of Ticagrelor	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	AUCt of AR-C124910XX	Area under the plasma concentration of AR-C124910XX versus time curve from time zero to time of last quantifiable concentration	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
Secondary	Cmax of AR-C124910XX	Maximum plasma concentration of AR-C124910XX	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
Secondary	AUCinf of AR-C124910XX	Area under the plasma concentration of AR-C124910XX versus time curve from time zero to time infinity	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
Secondary	Tmax of AR-C124910XX	Time to maximum concentration of AR-C124910XX	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
Secondary	t1/2 of AR-C124910XX	Apparent terminal half-life of AR-C124910XX	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