Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-348 in Healthy Volunteers

February 13, 2020 updated by: Chong Kun Dang Pharmaceutical

Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-348 in Healthy Adult Volunteers

Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D326 and D337 in healthy adult volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

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
      • Gyeonggi-do, 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

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. 19 ≤ age ≤ 45
  2. Health Volunteers
  3. Subject who agreeds to participate in this clinical trial voluntarily

Exclusion Criteria:

1. Subject who cannot participate in a clinical trial based on the PI's judgment

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 A
CKD-828, D326, D337, CKD-F1, CKD-F2
Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337
Each arm has a different order for taking IP
Experimental: Sequence B
CKD-828, D326, D337, CKD-F1, CKD-F2
Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337
Each arm has a different order for taking IP
Experimental: Sequence C
CKD-828, D326, D337, CKD-F1, CKD-F2
Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337
Each arm has a different order for taking IP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 0 hour ~ 144 hour
Maximum plasma concentration of the drug
0 hour ~ 144 hour
AUCt
Time Frame: 0 hour ~ 144 hour
Area under the concentration-time curve from time zero to time
0 hour ~ 144 hour

Collaborators and Investigators

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

Sponsor

Chong Kun Dang Pharmaceutical

Collaborators

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)

June 4, 2019

Primary Completion (Actual)

August 26, 2019

Study Completion (Actual)

August 26, 2019

Study Registration Dates

First Submitted

February 10, 2020

First Submitted That Met QC Criteria

February 13, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • A86_02BE1902P

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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