Study to Compare Pharmacokinetic Characteristics of Eperi... | NCT02289274

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

NCT02289274

Sponsor

NVP Healthcare

Status

Withdrawn

Last Update Posted

Sep 9, 2019Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Healthy

Interventions

NVP-1203
Eperisone SR tab. + and Airtal tab.

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

internal decision

Expanded Access Info

Start Date

Nov 2019Estimated

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Nov 9, 2014

First Submission Date that Met QC Criteria

Nov 12, 2014

First Posted Date

Nov 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2019

Last Update Posted Date

Sep 9, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NVP-1203	Drug	NVP-1203(eperisone SR + aceclofenac)	NVP-1203	Eperisone SR + aceclofenac

Measure	Description	Time Frame
Area Under Curve(AUC) last		0-24hr

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bae K Seop, M.D.	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Navipharm		Suwon	Gyeonggi-do	16209	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C056498	aceclofenac

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided