A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions

NCT05347576 | Completed Phase 1

• 1 other identifier: A98_07BE2201
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions

Conditions

Type2Diabetes

Outcome Measures

Primary Outcomes (2)

• AUCt

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

  Pre-dose(0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 (h ) hours

• Cmax

  Maximum plasma concentration of the drug

  Pre-dose(0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 (h ) hours

Study Arms (2)

sequence 1

EXPERIMENTAL

Period 1- A single dose of 4 tablets(CKD-501 1T, D759 1T, D150 1T, D029 1T) under fed condition Period 2- A single dose of 2 tablets(CKD-393(2) 2T) under fed condition

Drug: CKD-393(2); Drug: CKD-501, D759, D150, D029

sequence 2

EXPERIMENTAL

Period 1- A single dose of 2 tablets(CKD-393(2) 2T) under fed condition Period 2- A single dose of 4 tablets(CKD-501 1T, D759 1T, D150 1T, D029 1T) under fed condition

Drug: CKD-393(2); Drug: CKD-501, D759, D150, D029

Interventions

CKD-393(2) DRUG

QD, PO

sequence 1; sequence 2

CKD-501, D759, D150, D029 DRUG

QD, PO

sequence 1; sequence 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.

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 are pregnant or breastfeeding.
• Those who are deemed inappropriate to participate in clinical trial by investigators.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

MeSH Terms

Interventions

lobeglitazone

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: April 21, 2022
• First Posted: April 26, 2022
• Study Start: April 21, 2022
• Primary Completion: May 2, 2022
• Study Completion: May 9, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

KR (1)