A Clinical Trial to Compare the Pharmacokinetic and Safety of CKD-828 20/1.25mg

Hypertension Clinical Trial

Official title:

A Randomized, Open-label, Single Dose, 4-period Replicate Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-828 in Healthy Volunteers Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05881707
• Other study ID #: A30_18BE2304
• Status: Completed
• Phase: Phase 1
• Start date: July 4, 2023
• Est. completion date: September 27, 2023

Study information

• Verified date: October 2023
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A clinical trial to compare the pharmacokinetic and safety of CKD-828 20/1.25mg

Description:

A randomized, open-label, single dose, 4-period replicate crossover study to evaluate the pharmacokinetic profiles and safety of CKD-828 in healthy volunteers under fasting conditions

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 27, 2023
• Est. primary completion date: September 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 54 Years

Eligibility

Inclusion Criteria:

1. Healthy adult aged = 19 and <55 at screening

2. Those who have a body mass index (BMI) of not less than 18.0 kg/m2 and not more than 30.5 kg/m2 and weigh not less than 55 kg

3. A person who has no congenital or chronic disease within the last three years and has no pathological symptoms or findings as a result of medical examination

4. A person who is deemed suitable for testing as a result of laboratory tests (hematological tests, hemochemistry tests, urinary tests, virus/bacterial tests, etc.) conducted by the tester according to the characteristics of the drug, vital signs, electrocardiogram tests, etc

5. A person who has signed a written consent approved by the Chonbuk National University Hospital Clinical Trial Review Board (IRB) after fully explaining the purpose, contents, etc. of the test before participating in the test

6. A person who has agreed not to donate sperm during the pre-clinical period and one month after taking the last clinical drug (non-hormonal contraceptive method: condom use, intrauterine device (IUD, IUS), tubular ligation, cervical cap, contraceptive diaphragm, etc.)

7. A person who has the ability and will to participate during the pre-test period

Exclusion Criteria:

1. Clinically significant blood, kidneys (severe renal dysfunction, etc.), endocrine, respiratory, gastrointestinal, urology, cardiovascular (within one month of severe aortic stenosis, instability, or myocardial infarction), liver (severe hepatic dysfunction, biliary obstruction, bile congestion, etc.), mental, nerve or immune disease simple dental evidence

2. A person who has a history of gastrointestinal diseases (e.g., esophageal diseases such as esophageal dysphagia or esophageal stenosis, Crohn's disease) or surgery (excluding simple appendectomy, hernia, or extraction surgery) that can affect drug absorption

3. A person who shows the following figures as a result of performing an inspection laboratory inspection during screening

• ALT or AST > Twice the upper limit of the normal range

• CK> 3 times the upper limit of the normal range

• eGFR <60 mL/min/1.73 m2 using CKD-EPI formula

4. Screening Those with a history of regular alcohol consumption exceeding 210 g/week within 6 months (Beer (5%) 1 glass (250 mL) = 10 g, Soju (20%) 1 glass (50 mL) = 8 g, Wine (12%) 1 glass (125 mL) = 12 g)

5. Smokers with 20 or more cigarettes per day within 6 months of screening

6. A person who has taken another clinical trial drug or biological equivalence test drug within six months prior to the first administration of the clinical trial drug

7. Person who falls under the following results of vital signs measurement during screening

? Those with systolic blood pressure of less than 90 mmHg, 140 mmHg or more, or diastolic blood pressure of less than 60 mmHg or 90 mmHg or more in the sedentary state

8. A person who has a history of serious alcohol or drug misuse within one year of screening

9. A person who has taken a drug known to significantly induce or inhibit drug metabolites within 30 days prior to the first administration of a drug for clinical trials

10. A person who has taken prescription or non-prescription drugs within 10 days prior to the first administration of a clinical trial drug

11. A person who has donated all blood within two months before the first administration of a clinical trial drug, or has donated blood components within one month, or received a blood transfusion within one month

12. Those with severe acute/chronic medical and mental conditions that may increase risk or interfere with the interpretation of test results due to the administration and participation in clinical trial drugs

13. A person who has overreaction to clinical trial drugs, the main ingredients and components of clinical trial drugs, or other dihydropyridine-based drugs

14. Patients with hereditary angioedema or patients with a history of angioedema when treated with ACE inhibitors or angiotensin II receptor antagonists

15. Shock patients (including cardiac shock)

16. Pregnant or lactating women

17. Other persons deemed inappropriate by the tester to participate in this test

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• CKD-828, D064, D702
QD, PO

Locations

Country	Name	City	State
Korea, Republic of	Jeonbuk National University Hospital	Seoul

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-828	Area under the concentration-time curve time zero to time	Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Primary	Cmax of CKD-828	Maximum plasma concentration of the drug	Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour