Study to Evaluate the Safety and Pharmacokinetics of CKD-379

A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-379 in Healthy Volunteers Under Fed Conditions

A study to compare the pharmacokinetics and safety between CKD-379 and D759, D745, D029, D150 combination

Study Overview

• Status: Active, not recruiting
• Conditions: Type II Diabetes Mellitus
• Intervention / Treatment: Drug: CKD-379; Drug: D759+D745+D029+D150

Detailed Description

A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-379 in healthy volunteers under fed conditions

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Between 19 aged and 50 aged in healthy adult
• 18.0kg/m2≤body mass index(BMI)≤27.0kg/m2 and 50.0kg≤Body weight≤90.0kg

Exclusion Criteria:

• Have clinical significant medical history or disease that blood, kidney(moderate nephropathy and etc.), endocrine system(type I or type II diabetes mellitus, diabetic ketoacidosis, diabetic coma and etc.), respiratory system, gastrointestinal system, urinary system, cardiovascular system(heart failure, Torsades de pointes and etc.), liver(moderate liver disorder and etc.), mental system, nervous system, immune system
• Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery
• Those who are pregnant or breastfeeding
• Those who are deemed inappropriate to participate in clinical trial by investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Period 1: Reference drug(D759+D745+D029+D150) Period 2: Test drug(CKD-379)	Drug: CKD-379; 2 tablet administration under fed condition; Drug: D759+D745+D029+D150; 4 tablet co-administration under fed condition
Experimental: Sequence 2; Period 1: Test drug(CKD-379) Period 2: Reference drug(D759+D745+D029+D150)	Drug: CKD-379; 2 tablet administration under fed condition; Drug: D759+D745+D029+D150; 4 tablet co-administration under fed condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt	Maximum plasma concentration of the drug	0~48hours
Cmax	Area under the concentration-time curve from the time of dosing to the last measurable concentration	0~48hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Seol Ju Moon, M.D, Ph.D., Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2023
• Primary Completion (Actual): June 19, 2023
• Study Completion (Estimated): October 30, 2023

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: A125_04BE2302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No