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

Chong Kun Dang Pharmaceutical1 site in 1 country45 target enrollmentApril 4, 2024

DrugsTest: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 45
Locations: 1
Primary Endpoint: Cmax of Lobeglitazone, Empagliflozin, Metformin
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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)

Registry

clinicaltrials.gov

Start Date

April 4, 2024

End Date

May 17, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Cmax of Lobeglitazone, Empagliflozin, Metformin

Time Frame: 0 hour ~ 48 hour after drug administration

Pharmacokinetic characterization

AUCt of Lobeglitazone, Empagliflozin, Metformin

Time Frame: 0 hour ~ 48 hour after drug administration

Pharmacokinetic characterization

Secondary Outcomes

CL/F of Lobeglitazone, Empagliflozin, Metformin(0 hour ~ 48 hour after drug administration)
AUC∞ of Lobeglitazone, Empagliflozin, Metformin(0 hour ~ 48 hour after drug administration)
Tmax of Lobeglitazone, Empagliflozin, Metformin(0 hour ~ 48 hour after drug administration)
T1/2 of Lobeglitazone, Empagliflozin, Metformin(0 hour ~ 48 hour after drug administration)
Vd/F of Lobeglitazone, Empagliflozin, Metformin(0 hour ~ 48 hour after drug administration)