Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic of CKD-501, D745, and D150 for Healthy Subjects in Fed State.

A Randomized, Open-label, Single Oral Dosing, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the Co-administration of CKD-501, D745, and D150 for Healthy Subjects in Fed State

This is a Randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of CKD-383 and the co-administration of CKD-501, D745, and D150 for healthy subjects in fed state

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG

Detailed Description

Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 or 4 tablets in single dose: actual medication)

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of
    • Chung-Ang University Gwangmyeong Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Healthy adults aged 19 to 65 years
• Based on screening, no congenital or chronic disease, who have no athological symptoms or findings(If necessary, EEG, ECG, chest and gastroscopy or gastrointestinal radiation, Examination)
• within 5 years prior to the start of the trial(Period 1 administration) of any clinically significant mental medical history
• Other inclusion criteria, as defined in the protocol

Exclusion Criteria:

• who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period 1 administration)
• Other exclusive 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 A; Phase 1: CKD-501 1 tablet, D745 1 tablet, D150 2 tablets(Reference); Phase 2: CKD-383 2 tablets(Test)	Drug: Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG; At around 8 a.m., take Test drug or Reference drug 1,2,3(oral) with 200 mL of water at room temperature.; Other Names: Test: CKD-383, Reference1: CKD-501, Reference2: D745, Reference3: D150
Experimental: Group B; Phase 1: CKD-383 2 tablets(Test); Phase 2: CKD-501 1 tablet, D745 1 tablet, D150 2 tablets(Reference)	Drug: Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG; At around 8 a.m., take Test drug or Reference drug 1,2,3(oral) with 200 mL of water at room temperature.; Other Names: Test: CKD-383, Reference1: CKD-501, Reference2: D745, Reference3: D150

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt of Lobeglitazone, Empagliflozin, Metformin	Pharmacokinetic characterization	0 hour ~ 48 hour after drug administration
Cmax of Lobeglitazone, Empagliflozin, Metformin	Pharmacokinetic characterization	0 hour ~ 48 hour after drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC∞ of Lobeglitazone, Empagliflozin, Metformin	Pharmacokinetic characterization	0 hour ~ 48 hour after drug administration
Tmax of Lobeglitazone, Empagliflozin, Metformin	Pharmacokinetic characterization	0 hour ~ 48 hour after drug administration
T1/2 of Lobeglitazone, Empagliflozin, Metformin	Pharmacokinetic characterization	0 hour ~ 48 hour after drug administration
CL/F of Lobeglitazone, Empagliflozin, Metformin	Pharmacokinetic characterization	0 hour ~ 48 hour after drug administration
Vd/F of Lobeglitazone, Empagliflozin, Metformin	Pharmacokinetic characterization	0 hour ~ 48 hour after drug administration

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Yun Hwan Oh, PI, Chung-Ang University Gwangmyeong Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2024
• Primary Completion (Actual): April 29, 2024
• Study Completion (Actual): May 17, 2024

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: June 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; Sodium-Glucose Transporter 2 Inhibitors; Metformin; Empagliflozin
• Other Study ID Numbers: A101_05BE2315

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