NCT05452525

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
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2022

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

July 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

July 26, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2022

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2022

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

1 month

First QC Date

July 6, 2022

Last Update Submit

October 17, 2022

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 (6)

Sequence 1

EXPERIMENTAL

Period 1: Test drug(CKD-379 I) Period 2: Test drug(CKD-379 II) Period 3: Reference drug(D759+D745+D150)

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

Sequence 2

EXPERIMENTAL

Period 1: Test drug(CKD-379 I) Period 2: Reference drug(D759+D745+D150) Period 3: Test drug(CKD-379 II)

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

Sequence 3

EXPERIMENTAL

Period 1: Test drug(CKD-379 II) Period 2: Reference drug(D759+D745+D150) Period 3: Test drug(CKD-379 I)

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

Sequence 4

EXPERIMENTAL

Period 1: Test drug(CKD-379 II) Period 2: Test drug(CKD-379 I) Period 3: Reference drug(D759+D745+D150)

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

Sequence 5

EXPERIMENTAL

Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379 I) Period 3: Test drug(CKD-379 II)

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

Sequence 6

EXPERIMENTAL

Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379 II) Period 3: Test drug(CKD-379 I)

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

Interventions

CKD-379 IDRUG

1 tablet administration under fed condition

Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
CKD-379 IIDRUG

1 tablet administration under fed condition

Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
D759+D745+D150DRUG

3 tablet coadministration under fed condition

Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6

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 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

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

July 6, 2022

First Posted

July 11, 2022

Study Start

July 26, 2022

Primary Completion

August 27, 2022

Study Completion

September 21, 2022

Last Updated

October 18, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)