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Trial record 80 of 3094 for:    Area Under Curve AND Healthy

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

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ClinicalTrials.gov Identifier: NCT01869985
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : March 11, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: HCP1104 / Mulex Tab. and Airtal Tab. Phase 1

Detailed Description:
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Aceclofenac

Arm Intervention/treatment
Experimental: HCP1104
HCP1104
Drug: HCP1104 / Mulex Tab. and Airtal Tab.
HCP1104 / Eperisone plus Aceclofenac

Active Comparator: Mulex Tab. and Airtal Tab.
Eperisone Hydrochloride and Aceclofenac
Drug: HCP1104 / Mulex Tab. and Airtal Tab.
HCP1104 / Eperisone plus Aceclofenac




Primary Outcome Measures :
  1. Area Under Curve(AUC) last [ Time Frame: 0, 20, 40min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24h hours post-dose ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869985


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited

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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01869985     History of Changes
Other Study ID Numbers: HM-EPAC-102
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014

Keywords provided by Hanmi Pharmaceutical Company Limited:
HCP1104
Eperisone Hydrochloride
Aceclofenac

Additional relevant MeSH terms:
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Aceclofenac
Diclofenac
Eperisone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Muscle Relaxants, Central
Neuromuscular Agents
Parasympatholytics
Autonomic Agents
Vasodilator Agents