Pharmacokinetics and Safety/Tolerability of CKD-379 | NCT05719155

Studies
Pharmacokinetics and Safety/Tolerability of CKD-379

NCT05719155

Sponsor

Chong Kun Dang Pharmaceutical

Status

Completed

Last Update Posted

May 11, 2023Actual

Enrollment

32Actual

Phase

Phase 1

Conditions

Type II Diabetes Mellitus

Interventions

CKD-379
D759+D745+D150

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 27, 2023Actual

Primary Completion Date

Mar 23, 2023Actual

Completion Date

Apr 10, 2023Actual

First Submitted Date

Jan 30, 2023

First Submission Date that Met QC Criteria

Jan 30, 2023

First Posted Date

Feb 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2023

Last Update Posted Date

May 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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, 2-period, 2-treatment, crossover study to compare the pharmacokinetics and safety/tolerability of CKD-379 in healthy subjects under fed conditions

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence 1	Experimental	Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379)	Drug: CKD-379 Drug: D759+D745+D150
Sequence 2	Experimental	Period 1: Test drug(CKD-379) Period 2: Reference drug(D759+D745+D150)	Drug: CKD-379 Drug: D759+D745+D150

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CKD-379	Drug	1 tablet administration under fed condition	Sequence 1 Sequence 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaeseong Oh, M.D., Ph.D.	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul	Jongno-gu	03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided