Pharmacokinetics and Safety/Tolerability of CKD-379

May 10, 2023 updated by: Chong Kun Dang Pharmaceutical

A Randomized, Open-label, Single Dose, 2-period, 2-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-379 and Coadministration of D759, D745 and D150 in Healthy Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 03080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1
Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379)
Drug: CKD-379
1 tablet administration under fed condition
Drug: D759+D745+D150
3 tablet coadministration under fed condition
Experimental: Sequence 2
Period 1: Test drug(CKD-379) Period 2: Reference drug(D759+D745+D150)
Drug: CKD-379
1 tablet administration under fed condition
Drug: D759+D745+D150
3 tablet coadministration under fed condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 0~48hours
Maximum plasma concentration of the drug
0~48hours
AUClast
Time Frame: 0~48hours
Area under the concentration-time curve from the time of dosing to the last measurable concentration
0~48hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: Jaeseong Oh, M.D., Ph.D., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2023

Primary Completion (Actual)

March 23, 2023

Study Completion (Actual)

April 10, 2023

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

January 30, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A125_02BE2226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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