NCT02289274

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2019

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
5 years until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 9, 2019

Status Verified

September 1, 2019

Enrollment Period

1 month

First QC Date

November 9, 2014

Last Update Submit

September 5, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Area Under Curve(AUC) last

    0-24hr

Study Arms (2)

NVP-1203

EXPERIMENTAL

NVP-1203

Drug: NVP-1203

Eperisone SR tab. + and Airtal tab.

ACTIVE COMPARATOR

Eperisone HCl and aceclofenac

Drug: Eperisone SR tab. + and Airtal tab.

Interventions

NVP-1203DRUG

NVP-1203(eperisone SR + aceclofenac)

Also known as: Eperisone SR + aceclofenac
NVP-1203
Eperisone SR tab. + and Airtal tab.DRUG

Eperisone SR and aceclofenac

Also known as: Eperisone SR tab + airtal tab.
Eperisone SR tab. + and Airtal tab.

Eligibility Criteria

Age19 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Use of any prescription medication within 14 days prior to Day 1
  • Use of any medication within 7 days prior to Day 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Navipharm

Suwon, Gyeonggi-do, 16209, South Korea

Location

MeSH Terms

Interventions

aceclofenac

Study Officials

  • Bae K Seop, M.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2014

First Posted

November 13, 2014

Study Start

November 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

September 9, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)