A Clinical Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379

A Randomized, Open-label, Single Dose, Crossover, Phase Ⅰ Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379 in Healthy Volunteers

This is a randomized, open-label, single dose, crossover, phase Ⅰ trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-379 in healthy volunteers

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug; Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug

Detailed Description

Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Healthy adults aged 19 to 54 years
• BMI measurement result is 18.0 kg/m2 to 30 kg/m2
• Written informed consent
• Other inclusion criteria, as defined in the protocol

Exclusion Criteria:

• History of clinically significant liver, kidney, blood, digestive, respiratory, endocrine, cardiovascular, neurological, mental, or immune system disorders
• AST or ALT or total bilirubin > 1.5 times the upper limit of normal range
• History of regular alcohol consumption > 21 units/week within 6 months at the time of screening
• Participated in a clinical trial within 6 months prior to 1st IP dosing
• Other exclusive inclusion criteria, as defined in the protocol

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: Group 1; Phase 1: CKD-379 Test drug; Phase 2: CKD-379 Reference drug	Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug; oral, once; Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug; oral, once
Experimental: Group 2; Phase 1: CKD-379 Reference drug; Phase 2: CKD-379 Test drug	Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug; oral, once; Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug; oral, once

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUCt of Empagliflozin, sitagliptin, metformin	0 hour ~ 48 hour after drug administration
Cmax of Empagliflozin, sitagliptin, metformin	0 hour ~ 48 hour after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
AUCinf of Empagliflozin, sitagliptin, metformin	0 hour ~ 48 hour after drug administration
Tmax of Empagliflozin, sitagliptin, metformin	0 hour ~ 48 hour after drug administration
t1/2 of Empagliflozin, sitagliptin, metformin	0 hour ~ 48 hour after drug administration
CL/F of Empagliflozin, sitagliptin, metformin	0 hour ~ 48 hour after drug administration
Vd/F of Empagliflozin, sitagliptin, metformin	0 hour ~ 48 hour after drug administration

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Jaeyong Jeong, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Actual): December 6, 2023
• Study Completion (Actual): December 6, 2023

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

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; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Sodium-Glucose Transporter 2 Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Empagliflozin; Sitagliptin Phosphate
• Other Study ID Numbers: A125_05FDI2310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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