Partial Replicated Crossover Clinical Study to Compare Pharmacokinectic Characteristics of Eperisone Hydrochloride and Aceclofenac With HCP1104 Treatment to Those of Co-administration of Eperisone Hydrochloride 50mg Tablet and Aceclofenac 100mg Tablet in Healthy Adult Male Volunteers
A Randomized, Open-label, Single Dose, 3-sequence and 3-period Partial Replicated Crossover Clinical Study to Compare Pharmacokinectic Characteristics of Eperisone Hydrochloride and Aceclofenac With HCP1104 Treatment to Those of Co-administration of Eperisone Hydrochloride 50mg Tablet and Aceclofenac 100mg Tablet in Healthy Adult Male Volunteers
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Aug 2013
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2013
CompletedFirst Posted
Study publicly available on registry
June 5, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedMarch 11, 2014
March 1, 2014
1 month
June 3, 2013
March 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area Under Curve(AUC) last
0, 20, 40min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24h hours post-dose
Study Arms (2)
HCP1104
EXPERIMENTALHCP1104
Mulex Tab. and Airtal Tab.
ACTIVE COMPARATOREperisone Hydrochloride and Aceclofenac
Interventions
HCP1104 / Eperisone plus Aceclofenac
Eligibility Criteria
You may qualify if:
- Healthy male volunteers, age between 20 and 45
- BMI of \>20kg/m2 and \<28kg/m2 subject
- Informed of the investigational nature of this study and voluntarily agree to participate in this study
You may not qualify if:
- Use of any prescription medication within 14 days prior to Day 1
- Use of any medication within 7 days prior to Day 1
- Participation in another clinical study within 60 days prior to start of study drug administration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, South Korea
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2013
First Posted
June 5, 2013
Study Start
August 1, 2013
Primary Completion
September 1, 2013
Study Completion
January 1, 2014
Last Updated
March 11, 2014
Record last verified: 2014-03