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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: CKD-828, D064, D702

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Jeonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Period 1: D064, D702 - A single oral dose of 2 tablets; Period 2: CKD-828 - A single oral dose of 1 tablet; Period 3: D064, D702 - A single oral dose of 2 tablets; Period 4: CKD-828 - A single oral dose of 1 tablet	Drug: CKD-828, D064, D702; QD, PO
Experimental: Sequence 2; Period 1: CKD-828 - A single oral dose of 1 tablet; Period 2: D064, D702 - A single oral dose of 2 tablets; Period 3: CKD-828 - A single oral dose of 1 tablet; Period 4: D064, D702 - A single oral dose of 2 tablets	Drug: CKD-828, D064, D702; QD, PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Mingul Kim, Ph.D, Jeonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2023
• Primary Completion (Actual): September 2, 2023
• Study Completion (Actual): September 27, 2023

Study Registration Dates

• First Submitted: May 21, 2023
• First Submitted That Met QC Criteria: May 21, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: A30_18BE2304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No