A Clinical Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379

January 2, 2024 updated by: Chong Kun Dang Pharmaceutical

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)

Study Type

Interventional

Enrollment (Actual)

28

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
      • Seongnam, Korea, Republic of
        • Seoul National University Bundang 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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults aged 19 to 54 years
  • BMI measurement result is 18.0 kg/m2 to 30 kg/m2
  • Written informed consent
  • Other inclusion criteria, as defined in the protocol

Exclusion Criteria:

  • 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
  • Other exclusive inclusion criteria, as defined in the protocol

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: Group 1
  • Phase 1: CKD-379 Test drug
  • Phase 2: CKD-379 Reference drug
Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug
oral, once
Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug
oral, once
Experimental: Group 2
  • Phase 1: CKD-379 Reference drug
  • Phase 2: CKD-379 Test drug
Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug
oral, once
Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug
oral, once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUCt of Empagliflozin, sitagliptin, metformin
Time Frame: 0 hour ~ 48 hour after drug administration
0 hour ~ 48 hour after drug administration
Cmax of Empagliflozin, sitagliptin, metformin
Time Frame: 0 hour ~ 48 hour after drug administration
0 hour ~ 48 hour after drug administration

Secondary Outcome Measures

Outcome Measure
Time Frame
AUCinf of Empagliflozin, sitagliptin, metformin
Time Frame: 0 hour ~ 48 hour after drug administration
0 hour ~ 48 hour after drug administration
Tmax of Empagliflozin, sitagliptin, metformin
Time Frame: 0 hour ~ 48 hour after drug administration
0 hour ~ 48 hour after drug administration
t1/2 of Empagliflozin, sitagliptin, metformin
Time Frame: 0 hour ~ 48 hour after drug administration
0 hour ~ 48 hour after drug administration
CL/F of Empagliflozin, sitagliptin, metformin
Time Frame: 0 hour ~ 48 hour after drug administration
0 hour ~ 48 hour after drug administration
Vd/F of Empagliflozin, sitagliptin, metformin
Time Frame: 0 hour ~ 48 hour after drug administration
0 hour ~ 48 hour after drug administration

Collaborators and Investigators

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

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: Jaeyong Jeong, Seoul National University Bundang 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)

November 21, 2023

Primary Completion (Actual)

December 6, 2023

Study Completion (Actual)

December 6, 2023

Study Registration Dates

First Submitted

December 17, 2023

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A125_05FDI2310

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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