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

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT04304547
Collaborator
(none)
15
Enrollment
1
Location
3
Arms
1.9
Actual Duration (Months)
7.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: CKD-828, D097, D337, CKD-348 T1, CKD-348 T2
  • Drug: CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,
  • Drug: CKD-348 T2, CKD-348 T1, CKD-828, D097, D337
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Feb 4, 2020
Actual Primary Completion Date :
Apr 2, 2020
Actual Study Completion Date :
Apr 2, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cmax [0 hour ~ 144 hr]

      Maximum plasma concentration of the drug

    2. AUCt [0 hour ~ 144 hour]

      Area under the concentration time curve from time zero to time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of

    Sponsors and Collaborators

    • Chong Kun Dang Pharmaceutical

    Investigators

    • Principal Investigator: Jae Yong Chung, Seoul National University Bundang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chong Kun Dang Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT04304547
    Other Study ID Numbers:
    • A86_04BE1913P
    First Posted:
    Mar 11, 2020
    Last Update Posted:
    Aug 13, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 13, 2020