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

Phase 1
Completed
Conditions
Hypertension
Interventions
Drug: CKD-828, D064, D702
Registration Number
NCT05881707
Lead Sponsor
Chong Kun Dang Pharmaceutical
Brief Summary

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

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
44
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
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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

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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Sequence 2CKD-828, D064, D702* 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
Sequence 1CKD-828, D064, D702* 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
Primary Outcome Measures
NameTimeMethod
AUCt of CKD-828Pre-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

Area under the concentration-time curve time zero to time

Cmax of CKD-828Pre-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

Maximum plasma concentration of the drug

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Jeonbuk National University Hospital

🇰🇷

Seoul, Korea, Republic of

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