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NCT02289274 Clinical Trial

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

Healthy Clinical Trial

— NVP-1203  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02289274
Other study ID # NVP-1203-BE
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date November 2019
Est. completion date December 2019

Study information
Verified date September 2019
Source Navipharm Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

aceclofenac and eperisone(low back pain)

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 40 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• NVP-1203
NVP-1203(eperisone SR + aceclofenac)
• Eperisone SR tab. + and Airtal tab.
Eperisone SR and aceclofenac

Locations
Country Name City State
Korea, Republic of Navipharm Suwon-si Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
Navipharm Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area Under Curve(AUC) last 0-24hr
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