Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393

NCT05113693 | Completed Phase 1

• 1 other identifier: A98_05BE2118
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Objective \- Evaluation of the pharmacokinetic properties and safety of CKD-393 0.25/50/750 mg oral administration in healthy adults under fed condition.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-501, D759, H053

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

  Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hour

• Cmax of CKD-501, D759, H053

  Cmax: Maximum plasma concentration of the drug

  Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hour

Study Arms (2)

1

EXPERIMENTAL

Period 1 - A single dose of 4 tablets(CKD-501 1T, D759 1T, H053 2T) under fed condition. Period 2 - A single dose of 2 tablets(CKD-393 2T) under fed condition.

Drug: CKD-393; Drug: CKD-501, D759, H053

2

EXPERIMENTAL

Period 1 - A single dose of 2 tablets(CKD-393 2T) under fed condition. Period 2 - A single dose of 4 tablets(CKD-501 1T, D759 1T, H053 2T) under fed condition.

Drug: CKD-393; Drug: CKD-501, D759, H053

Interventions

CKD-393 DRUG

QD, PO

1; 2

CKD-501, D759, H053 DRUG

QD, PO

1; 2

Eligibility Criteria

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

You may qualify if:

• Healthy adult volunteers aged 19 ≤ \~ \< 55-year-old.
• Weight ≥55kg (man) or 45kg (woman), with calculated body mass index (BMI) of 17.5 ≤ \~ \< 30.5 kg/m2.
• Those who have no congenital diseases or chronic diseases within 3 years and have no abnormal symptoms or findings.
• Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
• Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
• Those who agree to contraception until the 1 month after last administration of clinical trial drugs.
• Those who have the ability and willingness to participate during the entire clinical trail.

You may not qualify if:

• Those who have clinically significant disease or medical history of heart failure, Hepatopathy, Type 1 Diabetes, Diabetic ketoacidosis, Edema, Renal dysfunction, galactose intolerance, glucose-galactose malabsorption. And Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) during clinical trial.
• Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of investigational drug.
• Those who have the test results written below
• AST, ALT \> 2 times higher than upper normal level
• Those who exceeding an alcohol consumption criteria(210g/week) within 6 months before the first administration of investigational drug.
• Beer 1 glass(250ml, Alcohol contents 5%) = 10g
• Soju 1 glass(50ml, Alcohol contents 20%) = 8g
• Wine 1 glass(125ml, Alcohol contents 12%) = 12g
• Those who exceeding smoking criteria(20 cigarettes/day) within 6 months before the first administration of investigational drug.
• Those who received investigational durg by participating in other clinical trial within 6 months before the first administration of investigational drug.
• Those who have vital sign written below
• systolic blood pressure ≥140 mmHg or \< 90 mmHg
• diastolic blood pressure ≥ 90 mmHg or \< 60 mmHg
• Those who have a drug or alcohol abuse history within 1 year before the first administration of investigational drug.
• Those who take barbiturate and related (causing induction or inhibition. of metabolism) drug within 30 days before the first administration of investigational drug.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lobeglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Min Gul Kim, M.D, Ph.D.

  Chonbuk 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: October 28, 2021
• First Posted: November 9, 2021
• Study Start: November 25, 2021
• Primary Completion: December 6, 2021
• Study Completion: December 10, 2021
• Last Updated: June 9, 2023

Record last verified: 2023-06

Locations

KR (1)