Clinical Trial to Evaluate the Food Effect on the Pharmac... | NCT01885520

Studies
Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Eperisone HCl SR Tablet 75mg

NCT01885520

Sponsor

NVP Healthcare

Status

Completed

Last Update Posted

Mar 25, 2016Estimated

Enrollment

28Actual

Phase

Phase 1

Conditions

Low Back Pain

Interventions

fasting condition
fed condition

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

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jun 15, 2013

First Submission Date that Met QC Criteria

Jun 24, 2013

First Posted Date

Jun 25, 2013Estimated

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

Mar 23, 2016

Last Update Posted Date

Mar 25, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 evaluate the food effect on the pharmacokinetics of eperisone HCl SR tablet

Detailed Description

eperisone hydrochloride(muscle relaxant)

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

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fasting condition	Experimental	eperisone SR administrated under fasting condition	Dietary Supplement: fasting condition
Fed condition	Active Comparator	eperisone SR administrated under fed condition	Dietary Supplement: fed condition

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fasting condition	Dietary Supplement	eperisone SR tablet 75mg administrated under fasting	fasting condition

Measure	Description	Time Frame
AUC		0-24h
Cmax		0-24h

Measure	Description	Time Frame
T1/2		0-24h
Tmax		0-24h

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male subjects age between 20 and 55 signed informed consent

Exclusion Criteria:

Hypotension or hypertension has a history of allergy reaction of this drug or other drugs

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yoon Yo Ran, M.D., Ph.D.	Kyungpook National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyungpook National University Hospital		Jung-gu	Daegu	700-721	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

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided