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

NCT05881707 | Completed Phase 1

• 1 other identifier: A30_18BE2304
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Sequence 1

EXPERIMENTAL

* 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

Sequence 2

EXPERIMENTAL

* 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

Interventions

CKD-828, D064, D702 DRUG

QD, PO

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 19 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult aged ≥ 19 and \<55 at screening
• 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
• 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
• 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
• 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
• 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.)
• A person who has the ability and will to participate during the pre-test period

You may not qualify if:

• 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
• 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
• 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
• 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)
• Smokers with 20 or more cigarettes per day within 6 months of screening
• 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
• 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
• A person who has a history of serious alcohol or drug misuse within one year of screening
• 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
• A person who has taken prescription or non-prescription drugs within 10 days prior to the first administration of a clinical trial drug
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Jeonbuk National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

2-(3,4-dimethoxyphenyl)-8-(4-hydroxy-3-methoxyphenyl)-6-methyl-2-isopropyl-6-azaoctanitrile

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mingul Kim, Ph.D

  Jeonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: May 31, 2023
• Study Start: July 4, 2023
• Primary Completion: September 2, 2023
• Study Completion: September 27, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

KR (1)