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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06483243

Enrollment

Registered

2024-07-03

Start date

2024-04-04

Completion date

2024-05-17

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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)

Interventions

DRUGTest: 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026