Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-339 in Healthy Volunteers

NCT07748702 | Not Yet Recruiting Phase 1

• 1 other identifier: A164_01BE2511
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetics and safety of CKD-339 in healthy volunteers.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-339

  Area under the plasma CKD-339 concentration-time curve from 0 to t

  From 0 to 72 hours postdose

• Cmax of CKD-339

  The maximum concentration of CKD-339 in plasma

  From 0 to 72 hours postdose

Study Arms (2)

Sequence A(Reference-Test)

EXPERIMENTAL

Period 1: A single oral dose of 2 tablets under fasting condition(D311, D107), Period 2: A single oral dose of 1 tablet under fasting condition(CKD-339)

Drug: CKD-339; Drug: D311, D107

Sequence B(Test-Reference)

EXPERIMENTAL

Period 1: A single oral dose of 1 tablet under fasting condition(CKD-339), Period 2: A single oral dose of 2 tablets under fasting condition(D311, D107)

Drug: CKD-339; Drug: D311, D107

Interventions

CKD-339 DRUG

QD, PO

Also known as: Test

Sequence A(Reference-Test); Sequence B(Test-Reference)

D311, D107 DRUG

QD, PO

Also known as: Reference

Sequence A(Reference-Test); Sequence B(Test-Reference)

Eligibility Criteria

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

You may qualify if:

• Healthy adults between the age of 19 and 55 (inclusive) at the time of screening test.
• Subjects with a body mass index(BMI) between 18 and 30 kg/m2(BMI = Weight(kg)/ Height(m)2)
• Male subjects weighing at least 50 kg
• Female subjects weighing at least 45 kg
• Subjects who do not have clinically meaningful congenital or chronic diseases and who do not have medical examination results (such as electroencephalogram, electrocardiogram, chest and gastroscopy or gastrointestinal radiography, if necessary) during screening visits.
• Subjects judged by investigators to be suitable for screening tests based on laboratory tests (e.g., blood tests, urine tests) and ECG, which were conducted according to the characteristics of the IP.
• Subjects who voluntarily signed and dated the informed consent form after fully understanding its contents.
• Subjects who had agreed to use medically appropriate contraceptive methods\* to exclude the possibility of pregnancy from the first dose of the IP to 14 days after the last dose, and not to donate sperm or ovum.
• contraceptive methods: Combination use of intrauterine device (IUD) or system (IUS), vasectomy, tubal ligation, tubal occlusion and barrier methods of contraception (male condoms, female condoms, cervical caps, contraceptive diaphragm, sponges, etc.) or the use of combined spermicide, involves the simultaneous use of two or more barrier methods.

You may not qualify if:

• Subjects who have taken a drug metabolase-inducing and inhibiting drug such as barbitals within one month prior to the first dosing date or a drug that may interfere with this test within 10 days prior to the first dose of IP.
• Subjects who had been administered investigational product from other clinical study or bioequivalence study within the 6 months prior to the first dose of IP.
• Subjects who donated whole blood within 8 weeks, or blood components within 2 weeks prior to the first dose of IP.
• Subjects who have a history of gastrointestinal resection that may affect the absorption of drugs.
• Subjects with a history of regular alcohol consumption meeting any of the following criteria within 1 month prior to the first dose of IP.
• Man: average alcohol consumption \> 21 cups/weeks
• Woman: average alcohol consumption \> 14 cups/weeks
• Patients with the following conditions
• Patients who have a history of hypersensitivity to main or component of clinical trial drugs and other dihydropyridine drugs
• Patients on angiotensin converting enzyme (ACE) inhibitor or not more than 36 hours after discontinuation of administration
• Patients with a history of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor antagonists (ARB) administration
• Patients with hereditary or idiopathic angioedema
• Patients with severe liver failure, cirrhosis or biliary obstruction, bile congestion
• Patients with diabetes or moderate to severe renal impairment (eGFR \< 60mL/min/1.73m2) who have been co-administered with alliskyrene
• Patients with primary aldosteronism

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Bumin Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Taegon Hong, M.D.

CONTACT

+82-2-2620-0251; tghong@bumin.co.kr

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: July 28, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): October 6, 2026
• Study Completion (Estimated): October 12, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)