Pharmacokinetics and Safety/Tolerability Profile of CKD-379

A Randomized, Open-label, Single Dose, 3-period, 6-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-379 and Coadministration of D759, D745 and D150 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05452525

Enrollment

Registered

2022-07-11

Start date

2022-07-26

Completion date

2022-09-21

Last updated

2022-10-18

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

Conditions

Type II Diabetes Mellitus

Brief summary

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

Detailed description

A randomized, open-label, single dose, 3-period, 6-treatment, crossover study to compare the pharmacokinetics and safety/tolerability of CKD-379 in healthy subjects under fed conditions

Interventions

DRUGCKD-379 I

1 tablet administration under fed condition

DRUGCKD-379 II

1 tablet administration under fed condition

DRUGD759+D745+D150

3 tablet coadministration under fed condition

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Have clinical significant medical history or disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, digestive system, urinary system, endocrine system(Type I or Type II Diabetes Mellitus, diabetic ketoacidosis ect.), hematological system, cardiovascular system(heart failure, Torsades de pointes etc.), mental illness * Have clinical significant medical history or disease that urinary tract infection or genital infection including urosepsis, pyelonephritis * Have a gastrointestinal disease(Crohn's disease, ulcer ect.) 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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

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