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Study to Compare Pharmacokinetic Characteristics of Eperisone and Aceclofenac With NVP-1203

Sponsor
NVP Healthcare (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02289274
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
30
Anticipated Duration (Days)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the pharmacokinetics of NVP-1203 and coadministration of aceclofenac and eperisone HCl SR.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

aceclofenac and eperisone(low back pain)

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Partial Replicated Crossover Clinical Study to Compare Pharmacokinetic Characteristics of Eperisone and Aceclofenac With NVP-1203 Treatment to Those of Co-administration of Eperisone Hydrochloride Slow Release and Aceclofenac in Volunteers
Anticipated Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: NVP-1203

NVP-1203

Drug: NVP-1203
NVP-1203(eperisone SR + aceclofenac)
Other Names:
  • Eperisone SR + aceclofenac

    		•
    Active Comparator: Eperisone SR tab. + and Airtal tab.

    Eperisone HCl and aceclofenac

    Drug: Eperisone SR tab. + and Airtal tab.
    Eperisone SR and aceclofenac
    Other Names:
  • Eperisone SR tab + airtal tab.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area Under Curve(AUC) last [0-24hr]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 40 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy male volunteers, age between 19 and 45

    • BMI of >19kg/m2 and <28kg/m2 subject

    • Informed of the investigational nature of this study and voluntarily agree to participate in this study

    Exclusion Criteria:

    • Use of any prescription medication within 14 days prior to Day 1

    • Use of any medication within 7 days prior to Day 1

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Navipharm Suwon-si Gyeonggi-do Korea, Republic of 16209

    Sponsors and Collaborators

    • NVP Healthcare

    Investigators

    • Principal Investigator: Bae K Seop, M.D., Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NVP Healthcare
    ClinicalTrials.gov Identifier:
    NCT02289274
    Other Study ID Numbers:
    • NVP-1203-BE
    First Posted:
    Nov 13, 2014
    Last Update Posted:
    Sep 9, 2019
    Last Verified:
    Sep 1, 2019
    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
    Additional relevant MeSH terms:
    Aceclofenac
    Eperisone

    Study Results

    No Results Posted as of Sep 9, 2019