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

August 12, 2020 updated by: Chong Kun Dang Pharmaceutical

Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers

Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D097 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
      • Seongnam-si, 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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sequence A
CKD-828, D097, D337, CKD-348 T1, CKD-348 T2
Drug: CKD-828, D097, D337, CKD-348 T1, CKD-348 T2

Subject of sequence A takes IP in the following order:

  1. Each tablet of CKD-828 and D097 and D337 be taken at once
  2. CKD-348 T1 1 tablet
  3. CKD-348 T2 1 tabet
Other Names:
  • Sequence A
Active Comparator: Sequence B
CKD-828, D097, D337, CKD-348 T1, CKD-348 T2
Drug: CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,

Subject of sequence B takes IP in the following order:

  1. CKD-348 T1 1 tablet
  2. CKD-348 T2 1 tablet
  3. Each tablet of CKD-828 and D097 and D337 be taken at once
Other Names:
  • Sequence B
Active Comparator: Sequence C
CKD-828, D097, D337, CKD-348 T1, CKD-348 T2
Drug: CKD-348 T2, CKD-348 T1, CKD-828, D097, D337

Subject of sequence C takes IP in the following order:

  1. CKD-348 T2 1 tablet
  2. Each tablet of CKD-828 and D097 and D337 be taken at once
  3. CKD-348 T1 1 tablet
Other Names:
  • Sequence C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 0 hour ~ 144 hr
Maximum plasma concentration of the drug
0 hour ~ 144 hr
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

Investigators

  • Principal Investigator: Jae Yong Chung, 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)

February 4, 2020

Primary Completion (Actual)

April 2, 2020

Study Completion (Actual)

April 2, 2020

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • A86_04BE1913P

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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