Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-333 Low Dose in Healthy Volunteers

Cardiovascular Disease Clinical Trial

Official title:

A Randomized, Open-label, Single Dose, 3-period Partial Replicated Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-333 Low Dose in Healthy Volunteers Under Fasting Conditions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04611932
• Other study ID #: A70_08BE1907
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: November 11, 2020
• Est. completion date: April 27, 2021

Study information

• Verified date: October 2020
• Source: Chong Kun Dang Pharmaceutical
• Contact: Min-Gul Kim, Professor
• Phone: +82-63-259-3480
• Email: mgkim[@]jbcp.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, open-label, single dose, 3-period partial replicated crossover study to evaluate the pharmacokinetic profiles and safety of CKD-333 low dose in healthy volunteers under fasting conditions.

Description:

To healthy subjects of fifty-one (51), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days. Reference drug: 1) Cantabell Tab. 8/5mg 2) Lipitor Tab. 10mg / Test drug: CKD-333 8/5/10mg Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 51
• Est. completion date: April 27, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 54 Years

Eligibility

Inclusion Criteria:

1. Healthy adults over the age of 19 years and under the age of 55 years at the time of screening

2. Individuals who had 17.5 kg/m2 = Body Mass Index(BMI) < 30.5kg/m2 and men's total body weight = 55 kg, women's total body weight = 45 kg

• BMI = Weight(kg)/ Height(m)2

3. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years

4. Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital signs, ECG etc. performed at screening

5. Individuals who signed an informed consent form approved by the IRB of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational product

6. Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion

7. Individuals with the ability and willingness to participate the entire study period

Exclusion Criteria:

1. Individuals with a medical evidence or a history (excluding a dental history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune diseases.

2. Individuals with a medical history of gastrointestinal disease (e.g., gullet disease such as esophageal achalasia and esophagostenosis and Crohn's disease) or operations (excluding simple appendectomy, herniotomy or tooth extraction) that may affect drug absorption

3. Individuals with the following laboratory test results at screening:

• ALT or AST > 2x the upper limit of the normal range
• CK > 3x the upper limit of the normal range

4. History of regular alcohol consumption exceeding 210 g/week within the 6 months prior to screening (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)

5. Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening

6. Individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within the 6 months prior to the first dose of this study

7. Following vital signs results at screening

• Sitting systolic blood pressure = 140 mmHg or < 90 mmHg and/or sitting diastolic blood pressure =90 mmHg or <60 mmHg

8. Individuals with a medical history of significant alcohol or drug abuse within one year prior to the screening

9. Individuals who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first dose of investigational product(s)

10. Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first dose of investigational product(s)

11. Individuals who donated whole blood within the 2 months, or blood components within 1 month prior to the first dose of the investigational product(s)

12. Individuals with severe acute/chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product(s) administration, or may interfere with the interpretation of study results

13. Individuals with hypersensitivity to investigational products or the investigational products ingredients or dihydropyridine drugs

14. Patient with hyperkalemia

15. Patients with hepatopathy

16. Patients with hereditary angioedema, ACE inhibitors or angiotensin ? receptor antagonists who have a history of angioedema

17. Primary hyperaldosteronism

18. Patients with aortic valve stenosis, mitral (valve) stenosis, hypertrophic obstructive cardiomyopathy

19. Patients with ischemic heart disease, ischemic cardiovascular disease, cerebrovascular disease

20. Patients with Intravascular volume depletion

21. Patients with nephropathy (eGFR<60 ml/min/1.73 m2)

22. Patients with renal artery stenosis

23. Patients with muscle disease

24. Patients with Hypothyroidism

25. Women who are pregnant or may be pregnant

26. Patients with a history of muscle toxicity when using statins or fibrates

27. Patients who are taking glecaprevir/pibrentasvir

28. Patients with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.

29. Individuals who were deemed to be inappropriate to participate in the study by the investigator

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• CKD-330 Tab. and D090 Tab.
1T
• CKD-333 Tab.
1T

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 CKD-330, D090, CKD-333	Area under the CKD-330/D090/CKD-333 concentration in blood-time curve from zero to final	Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Primary	Cmax of CKD-330, D090, CKD-333	The maximum CKD-330/D090/CKD-333 concentration in blood sampling time t	Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours