Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic After Oral Administration of CKD-341 and D958 in Healthy Adults

NCT05921435 | Completed Phase 1

• 1 other identifier: A126_02BE2303
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-341

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• area under curve(AUC) of CKD-341, D958

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

  Pre-dose(0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 144 hours

• Cmax of CKD-341, D958

  The maximum CKD-341, D958 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, 7, 8, 10, 12, 24, 48, 72, 96, 144 hours

Study Arms (2)

Sequence A

EXPERIMENTAL

* Period 1: D958 * Period 2: CKD-341 * Period 3: D958 * Period 4: CKD-341

Drug: CKD-341, D958

Sequence B

EXPERIMENTAL

* Period 1: CKD-341 * Period 2: D958 * Period 3: CKD-341 * Period 4: D958

Drug: CKD-341, D958

Interventions

CKD-341, D958 DRUG

A single dose of 1tablet under fasting condition

Sequence A; Sequence B

Eligibility Criteria

• Age: 19 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult subjects aged over 19 years (inclusive) at the time of screening.
• Subjects weighing at least 50.0 kg with a Body Mass Index(BMI) between 18.0 kg/m2 and 30.0 kg/m2 (inclusive) at the time of screening.
• BMI(kg/m2) = weight (kg) / {height (m)}2
• Subjects with neither congenital nor chronic diseases requiring treatment, and no abnormal symptoms or findings upon medical examination.
• Subjects considered eligible for the study participation in accordance with the results of vital signs, physical examination, 12-lead ECG, and clinical laboratory tests at the time of screening.
• Subjects who have a full understanding in participation of the study, voluntarily provide a written consent in participation, and give full agreement in following the subject guidelines throughout the entire study period.

You may not qualify if:

• Subjects with any clinically significant past and present hepatic, renal, nervous, respiratory, endocrine, circulatory, oncologic, genitourinary, cardiovascular, digestive, musculoskeletal systemic diseases, psychosis disorders, or a medical history of at least one of the following conditions (past and present):
• ) Liver disorders and biliary obstructive disease 1-2) Kidney disorders 1-3) Shock 1-4) Hypokalemia, hyponatremia, hypercalcemia 1-5) Addison's syndrome 1-6) Primary aldosteronism 1-7) Aortic stenosis, mitral obstruction or hypertrophic obstructive cardiomyopathy 1-8) Renovascular hypertension or anuria 1-9) Hypotension 1-10) Vascular sclerosis or cerebral arteriosclerosis 1-11) Hyperuricemia (with gout or uric acid stone) or diabetes (including family history) 1-12) Hyperparathyroidism 1-13) Sympathectomy
• For women, pregnant (urine-HCG positive) or lactating women
• History of any clinically significant hypersensitivity reactions or hypersensitivity reactions to any of the IP main ingredients, formulation additives, and other drugs (including dihydropyridine derivatives, thiazide diuretics, or sulfonamide drugs).
• Subjects on lithium therapy or salt-restricted therapy
• Subjects with hereditary issues of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, etc.
• Subjects with a past medical history of gastrointestinal disease (Crohn's disease, ulcers, acute/chronic pancreatitis, etc.) or gastrointestinal surgeries (except for simple appendectomy and hernia repair) which may affect the absorption of the IP.
• Subjects with clinically significant 12-lead ECG findings including the following results at the time of screening:
• QTc \> 450 ms for men, QTc \> 470 ms for women
• PR interval \> 200 ms
• QRS duration \> 120 ms
• Subjects with laboratory test results as follows at the time of screening:
• Liver function test (AST, ALT, ALP, γ-GTP and total bilirubin) values exceeding twice the upper normal limit
• Creatinine values outside the reference ranges or eGFR \< 60 mL/min/1.73m2 (eGFR is estimated using the Chronic Kidney Disease Epidemiology Collaboration formula)
• CPK \> 2.5 times the upper limit of normal range on clinical laboratory tests

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

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: June 18, 2023
• First Posted: June 27, 2023
• Study Start: June 20, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 15, 2023
• Last Updated: February 5, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)