Status:
COMPLETED
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
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.
Detailed Description
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01869985
Start Date
August 1 2013
End Date
January 1 2014
Last Update
March 11 2014
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea