NCT05719155

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

February 27, 2023

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2023

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed
Last Updated

May 11, 2023

Status Verified

January 1, 2023

Enrollment Period

24 days

First QC Date

January 30, 2023

Last Update Submit

May 10, 2023

Conditions

Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Cmax

    Maximum plasma concentration of the drug

    0~48hours

  • AUClast

    Area under the concentration-time curve from the time of dosing to the last measurable concentration

    0~48hours

Study Arms (2)

Sequence 1

EXPERIMENTAL

Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379)

Drug: CKD-379Drug: D759+D745+D150

Sequence 2

EXPERIMENTAL

Period 1: Test drug(CKD-379) Period 2: Reference drug(D759+D745+D150)

Drug: CKD-379Drug: D759+D745+D150

Interventions

CKD-379DRUG

1 tablet administration under fed condition

Sequence 1Sequence 2
D759+D745+D150DRUG

3 tablet coadministration under fed condition

Sequence 1Sequence 2

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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 etc.), 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 etc.) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jaeseong Oh, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 8, 2023

Study Start

February 27, 2023

Primary Completion

March 23, 2023

Study Completion

April 10, 2023

Last Updated

May 11, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)