NCT05952219

Brief Summary

A study to compare the pharmacokinetics and safety between CKD-379 and D759, D745, D029, D150 combination

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 2, 2023

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

17 days

First QC Date

July 10, 2023

Last Update Submit

July 17, 2023

Conditions

Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • AUCt

    Maximum plasma concentration of the drug

    0~48hours

  • Cmax

    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+D029+D150) Period 2: Test drug(CKD-379)

Drug: CKD-379Drug: D759+D745+D029+D150

Sequence 2

EXPERIMENTAL

Period 1: Test drug(CKD-379) Period 2: Reference drug(D759+D745+D029+D150)

Drug: CKD-379Drug: D759+D745+D029+D150

Interventions

CKD-379DRUG

2 tablet administration under fed condition

Sequence 1Sequence 2
D759+D745+D029+D150DRUG

4 tablet co-administration 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/m2≤body mass index(BMI)≤27.0kg/m2 and 50.0kg≤Body weight≤90.0kg

You may not qualify if:

  • Have clinical significant medical history or disease that blood, kidney(moderate nephropathy and etc.), endocrine system(type I or type II diabetes mellitus, diabetic ketoacidosis, diabetic coma and etc.), respiratory system, gastrointestinal system, urinary system, cardiovascular system(heart failure, Torsades de pointes and etc.), liver(moderate liver disorder and etc.), mental system, nervous system, immune system
  • 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)

Chonbuk National University Hospital

Jeonju, 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

  • Seol Ju Moon, M.D, Ph.D.

    Chonbuk 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

July 10, 2023

First Posted

July 19, 2023

Study Start

June 2, 2023

Primary Completion

June 19, 2023

Study Completion

October 30, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations

KR(1)