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Navipharm: Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2

Sponsor
NVP Healthcare (Industry)
Overall Status
Completed
CT.gov ID
NCT04181437
Collaborator
(none)
40
Enrollment
1
Location
3
Arms
28
Actual Duration (Days)
43.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2 in Healthy Adult Subjects
Actual Study Start Date :
May 1, 2020
Actual Primary Completion Date :
May 17, 2020
Actual Study Completion Date :
May 29, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: NVP-1203-R1

Drug: NVP-1203-R1 1 tablet, oral dosing

Drug: NVP-1203-R1
1 tablet, Single oral dosing
Other Names:
  • NVP-1203-R1(A)

    		•
    Experimental: NVP-1203-R2

    Drug: NVP-1203-R2 1 tablet, oral dosing

    Drug: NVP-1203-R2
    1 tablet, Single oral dosing
    Other Names:
  • NVP-1203-R2(E)

    		•
    Experimental: NVP-1203-R1 and NVP-1203-R2

    Drug: NVP-1203-R1 1 tablet and NVP-1203-R2 1 tablet co-administration(oral dosing)

    Drug: NVP-1203-R1 and NVP-1203-R2
    NVP-1203-R1,1 tablet and NVP-1203-R2, 1 tablet, co-administration, single oral dosing
    Other Names:
  • NVP-1203-R1(A) and NVP-1203-R2(E)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetic interaction [0hours - 24hours]

      Area under the curve (AUC)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • healthy adult subjects who signed informed consent
    Exclusion Criteria:

    • Subjects has a history of allergy reaction of study drug ingredient

    • Subjects participated in another clinical trial within 6 months prior to administration of the study drug

    • Inadequate subject for the clinical trial by the investigator's decision

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kyungpook National University Hospital Daegu Dongdeok-ro Korea, Republic of 700-721

    Sponsors and Collaborators

    • NVP Healthcare

    Investigators

    • Principal Investigator: Yoon Y Ran, M.D., Kyungpook National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NVP Healthcare
    ClinicalTrials.gov Identifier:
    NCT04181437
    Other Study ID Numbers:
    • NVP-1203_DDI
    First Posted:
    Nov 29, 2019
    Last Update Posted:
    Sep 1, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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 Sep 1, 2020