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

Phase 1

Withdrawn

• Conditions: Healthy
• Interventions: Drug: NVP-1203; Drug: Eperisone SR tab. + and Airtal tab.

• Registration Number: NCT02289274
• Lead Sponsor: NVP Healthcare

Brief Summary

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

Detailed Description

aceclofenac and eperisone(low back pain)

Study Timeline

• Study First Submitted: 2014-11-09
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-13
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-09
• Study Start: 2019-11
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NVP-1203	NVP-1203	NVP-1203
Eperisone SR tab. + and Airtal tab.	Eperisone SR tab. + and Airtal tab.	Eperisone HCl and aceclofenac

Primary Outcome Measures

Name	Time	Method
Area Under Curve(AUC) last	0-24hr

Trial Locations

Locations (1)

Navipharm; 🇰🇷 Suwon-si, Gyeonggi-do, Korea, Republic of