NCT06204107

Brief Summary

This is a randomized, open-label, single dose, crossover, phase Ⅰ trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-379 in healthy volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_1 type-2-diabetes-mellitus

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

Study Start

First participant enrolled

November 21, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

15 days

First QC Date

December 17, 2023

Last Update Submit

January 2, 2024

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • AUCt of Empagliflozin, sitagliptin, metformin

    0 hour ~ 48 hour after drug administration

  • Cmax of Empagliflozin, sitagliptin, metformin

    0 hour ~ 48 hour after drug administration

Secondary Outcomes (5)

  • AUCinf of Empagliflozin, sitagliptin, metformin

    0 hour ~ 48 hour after drug administration

  • Tmax of Empagliflozin, sitagliptin, metformin

    0 hour ~ 48 hour after drug administration

  • t1/2 of Empagliflozin, sitagliptin, metformin

    0 hour ~ 48 hour after drug administration

  • CL/F of Empagliflozin, sitagliptin, metformin

    0 hour ~ 48 hour after drug administration

  • Vd/F of Empagliflozin, sitagliptin, metformin

    0 hour ~ 48 hour after drug administration

Study Arms (2)

Group 1

EXPERIMENTAL

* Phase 1: CKD-379 Test drug * Phase 2: CKD-379 Reference drug

Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Test drugDrug: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug

Group 2

EXPERIMENTAL

* Phase 1: CKD-379 Reference drug * Phase 2: CKD-379 Test drug

Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Test drugDrug: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug

Interventions

CKD-379(Empagliflozin+sitagliptin+metformin) Test drugDRUG

oral, once

Group 1Group 2
CKD-379(Empagliflozin+sitagliptin+metformin) Reference drugDRUG

oral, once

Group 1Group 2

Eligibility Criteria

Age19 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged 19 to 54 years
  • BMI measurement result is 18.0 kg/m2 to 30 kg/m2
  • Written informed consent

You may not qualify if:

  • History of clinically significant liver, kidney, blood, digestive, respiratory, endocrine, cardiovascular, neurological, mental, or immune system disorders
  • AST or ALT or total bilirubin \> 1.5 times the upper limit of normal range
  • History of regular alcohol consumption \> 21 units/week within 6 months at the time of screening
  • Participated in a clinical trial within 6 months prior to 1st IP dosing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug DevelopmentInvestigative TechniquesEvaluation Studies as Topic

Study Officials

  • Jaeyong Jeong

    Seoul National University Bundang 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

December 17, 2023

First Posted

January 12, 2024

Study Start

November 21, 2023

Primary Completion

December 6, 2023

Study Completion

December 6, 2023

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)