Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic After Oral Administration of CKD-341 and D956 in Healthy Adults

NCT06281132 | Completed Phase 1

• 1 other identifier: A126_03BE2316
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The objective was to evaluate and compare the pharmacokinetic profiles and safety after administration of test drug (CKD-341) and reference drugs (D956) in healthy adults.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• area under curve(AUC) of CKD-341, D956

  Area under the CKD-341, D958 concentration in blood-time curve from zero to

  Pre-dose(0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours

• Cmax of CKD-341, D956

  The maximum CKD-341, D956 concentration in blood sampling time

  Pre-dose(0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours

Study Arms (2)

Sequence 1

EXPERIMENTAL

* Period 1: D956 * Period 2: CKD-341 * Period 3: D956 * Period 4: CKD-341

Drug: CKD-341, D956

Sequence 2

EXPERIMENTAL

* Period 1: CKD-341 * Period 2: D956 * Period 3: CKD-341 * Period 4: D956

Drug: CKD-341, D956

Interventions

CKD-341, D956 DRUG

A single dose of 1 tablet under fasting condition

Also known as: PO, Tablet

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged between 19 to 55 years at the time of screening.
• Individuals who had 18.0 kg/m2 ≤ Body Mass Index (BMI) \< 30.5 kg/m2 and whose body weight was ≥ 55 kg.
• ☞ BMI = weight(kg) / height(m)2
• Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years.
• Individuals who were deemed to be appropriate as study subjects according to the laboratory tests (hematology, blood chemistry, urinalysis, serology, etc.), vital signs, 12-lead electrocardiogram (ECG), etc., performed at screening.
• Individuals who signed an informed consent form approved by the Institutional Review Board (IRB) of Jeonbuk National University Hospital and who decided to participate voluntarily in the study after being fully informed of the study objective, contents, etc. prior to participation.
• Individuals who consented to the use of reliable contraception (contraceptive methods other than hormones: use of condoms, intrauterine devices (IUD, IUS), tubal ligation, cervical cap, contraceptive diaphragm, etc.) during the clinical trial and not to donate sperm until 1 month after the last administration of investigational product(s).
• Individuals with the ability and willingness to participate the entire study period.

You may not qualify if:

• Individuals with medical evidence or a history (excluding a simple dental history of dental calculus, impacted tooth, wisdom tooth, etc.) of clinically significant hematological, renal, endocrine, respiratory, gastrointestinal(Active gastric ulcer), duodenal ulcer, etc.), urinary, cardiovascular (severe aortic valve stenosis, aArterial valve, mitral valve stenosis, obstructive hypertrophic cardiomyopathy, etc.), hepatic (severe hepatic impairment, etc.), psychiatric, neurologic, or immune diseases.
• Individuals with a medical history of gastrointestinal diseases (e.g., esophageal disorders such as esophageal achalasia or esophagostenosis, Crohn's disease) or operations (excluding simple appendectomy, herniotomy, or tooth extraction) that may affect drug absorption.
• Individuals with the following laboratory test result at screening:
• ALT or AST \> 2x the upper limit of the normal range
• CK \> 3x the upper limit of the normal range
• eGFR \<60 mL/min/1.73 m2 using CKD-EPI formula
• Individuals with a history of regular alcohol consumption exceeding 210 g/week within 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).
• Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening.
• Individuals who had taken investigational product(s) from other clinical trials or bioequivalence studies within 6 months prior to the first administration of the investigational product(s).
• Individuals with the following vital signs upon screening
• ☞ Systolic blood pressure ≥140 mmHg or \<90 mmHg and/or a diastolic blood pressure ≥90 mmHg or \<60 mmHg in sitting position.
• Individuals with a medical history of significant alcohol or drug abuse within 1 year prior to the screening.
• 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 administration of the investigational product(s).
• Individuals who had taken prescription or nonprescription drugs within 10 days prior to the first administration of the investigational product(s).
• Individuals who donated whole blood within 2 months or blood components within 1 month or have given blood transfusion within 1 month prior to the first administration of the investigational product(s).

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Jeonbuk National University Hospital

Jeonju, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

Tablets

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

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: February 20, 2024
• First Posted: February 28, 2024
• Study Start: March 22, 2024
• Primary Completion: May 7, 2024
• Study Completion: May 14, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)