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
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: HCP1104 / Mulex Tab. and Airtal Tab.
- Registration Number
- NCT01869985
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Mulex Tab. and Airtal Tab. HCP1104 / Mulex Tab. and Airtal Tab. Eperisone Hydrochloride and Aceclofenac HCP1104 HCP1104 / Mulex Tab. and Airtal Tab. HCP1104
- Primary Outcome Measures
Name Time Method Area Under Curve(AUC) last 0, 20, 40min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24h hours post-dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of