NCT01885520

Brief Summary

The purpose of this study is to evaluate the food effect on the pharmacokinetics of eperisone HCl SR tablet

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_1 low-back-pain

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

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

June 15, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

Same day

First QC Date

June 15, 2013

Last Update Submit

March 23, 2016

Conditions

Low Back Pain

Keywords

low back pain

Outcome Measures

Primary Outcomes (2)

  • AUC

    0-24h

  • Cmax

    0-24h

Secondary Outcomes (2)

  • T1/2

    0-24h

  • Tmax

    0-24h

Study Arms (2)

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

fasting conditionDIETARY_SUPPLEMENT

eperisone SR tablet 75mg administrated under fasting

fasting condition
fed conditionDIETARY_SUPPLEMENT

eperisone SR tablet 75mg administrated fed condition

Fed condition

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects age between 20 and 55 signed informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Jung-gu, Daegu, 700-721, South Korea

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yoon Yo Ran, M.D., Ph.D.

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 15, 2013

First Posted

June 25, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 25, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)