A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348(6)

NCT06112678 | Completed Phase 1

• 1 other identifier: A86_13BE2314
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

A phase I clinical trial to evaluate the tolerability and the pharmacokinetics of CKD-348(6).

Conditions

Hypertension; Dyslipidemias

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-348(6)

  AUCt: Area under the concentration-time curve from time zero to time

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

• Cmax of CKD-348(6)

  Cmax: 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, 7, 8, 10, 12, 24, 48, 72 hours

Study Arms (2)

Sequence 1

EXPERIMENTAL

Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-348(6) - A single oral dose of 1 tablet under fasting condition Period 3: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 4: CKD-348(6) - A single oral dose of 1 tablet under fasting condition

Drug: CKD-348(6); Drug: CKD-828, D097, D337

Sequence 2

EXPERIMENTAL

Period 1: CKD-348(6) - A single oral dose of 1 tablet under fasting condition Period 2: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-348(6) - A single oral dose of 1 tablet under fasting condition Period 4: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition

Drug: CKD-348(6); Drug: CKD-828, D097, D337

Interventions

CKD-348(6) DRUG

QD, PO

Sequence 1; Sequence 2

CKD-828, D097, D337 DRUG

QD, PO

Sequence 1; Sequence 2

Eligibility Criteria

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

You may qualify if:

• Healthy adult volunteers aged ≥ 19 years.
• Body weight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2
• Those who meet the blood pressure criteria during screening tests:
• Systolic Blood Pressure: 90 to 139 mmHg
• Diastolic Blood Pressure: 60 to 89 mmHg
• Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
• Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and ECG results at screening.
• Those who agree to contraception during the participation of clinical trial.
• Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

You may not qualify if:

• Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
• Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products.
• Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.
• Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
• Those who exceed an alcohol and cigarette consumption criteria write below within 1 month before the first administration of investigational products.
• Alcohol: Man - 21 glasses/week, Woman - 14 glasses/week (1glass: Soju 50mL, Wine 30mL, or beer 250mL)
• Smoking: 20 cigarettes/day
• Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism and hypersensitive to Sunset yellow FCF.
• Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
• Those who are deemed insufficient to participate in this clinical trial by investigators.
• Woman who are pregnant or breastfeeding.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

H plus Yangji hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension; Dyslipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Seung-Hyun Kang, M.D., Ph.D

  H Plus Yangji 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: October 29, 2023
• First Posted: November 1, 2023
• Study Start: January 4, 2024
• Primary Completion: February 19, 2024
• Study Completion: March 18, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

KR (1)